<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675024</url>
  </required_header>
  <id_info>
    <org_study_id>SP0913</org_study_id>
    <nct_id>NCT01675024</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects</brief_title>
  <official_title>A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine&#xD;
      after single and multiple doses of Rotigotine transdermal patch, and also to investigate the&#xD;
      safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of total Rotigotine for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of total Rotigotine for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC 0-tz) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to 24 hours at steady state (AUC(0-24h),ss) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration at steady state (Cmax,ss) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration normalized by Body Weight (kg) (Cmax, norm (BW)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration normalized by apparent dose (mg)(Cmax, norm (apparent dose)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration normalized by drug content of patch (mg) (Cmax, norm (mgdc)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-tz), norm (BW)) for single-dose application (Period 1)</measure>
    <time_frame>Perion 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-tz), norm (apparent dose)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by drug content of patch (mg) (AUC(0-tz), norm (mgdc)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to infinity (AUC(0-∞)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-∞), norm (apparent dose)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-∞), norm (BW)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero up to infinity normalized by drug content of patch (mg) (AUC(0-∞), norm (mgdc)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance (CL/F) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/f) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate constant of elimination (ke) for single-dose application (Period 1)</measure>
    <time_frame>Period 1; Day 1 to Day 3 of study</time_frame>
    <description>Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½) for multiple-dose application</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach a maximum plasma concentration at steady state (tmax,ss) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure.</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration at steady state normalized by body weight (kg) (Cmax,ss,norm(BW)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure.</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration at steady state normalized by apparent dose (mg) (Cmax, ss, norm (apparent dose)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure.</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration at steady state normalized by drug content of patch (mg) (Cmax, ss, norm (mgdc)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum plasma concentration at steady state (Cmin, ss) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by body weight (kg) (AUC(0-24h), ss, norm (BW)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by apparent dose (mg) (AUC(0-24), ss, norm (apparent dose)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by drug content of patch (mg) (AUC(0-24), ss, norm (mgdc)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance (CL/F) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate constant of elimination (ke) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 7 to Day 14 of study</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak to trough fluctuation (PTF) for multiple-dose application (Period 2)</measure>
    <time_frame>Period 2; Day 9 to Day 12 of study for this Outcome Measure</time_frame>
    <description>Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Rotigotine, Period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rotigotine, Period 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Period 2 (Day 7 to Day 14) all 24 subjects will receive 2 mg / 24 hours for 3 days then 4 mg / 24 hours for 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine, Period 1</intervention_name>
    <description>Formulation: transdermal&#xD;
Dosage: 2 mg / 24 hours once at Day 2&#xD;
Frequency: once every 24 hours&#xD;
Duration: from Day 1 to Day 3</description>
    <arm_group_label>Rotigotine, Period 1</arm_group_label>
    <other_name>Neupro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rotigotine, Period 2</intervention_name>
    <description>Formulation: transdermal&#xD;
Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12&#xD;
Frequency: once every 24 hours&#xD;
Duration: from Day 1 to Day 3</description>
    <arm_group_label>Rotigotine, Period 2</arm_group_label>
    <other_name>Neupro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese subjects&#xD;
&#xD;
          -  Healthy volunteers with normal body weight, female subject is willing to use a double&#xD;
             contraceptive barrier method or an oral hormonal contraceptive during the entire study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously participated in any Rotigotine study or participated in another clinical&#xD;
             study for an investigational drug&#xD;
&#xD;
          -  History of drug or alcohol abuse within the last 2 years&#xD;
&#xD;
          -  Suicide attempt or suicidal ideation in the past 6 months&#xD;
&#xD;
          -  Transient ischemic attack or stroke within the last 12 months&#xD;
&#xD;
          -  Current condition of epilepsy and / or seizures&#xD;
&#xD;
          -  History of significant skin hypersensitivity to adhesives or other transdermal&#xD;
             products or recently unsolved contact dermatitis&#xD;
&#xD;
          -  History or present condition of an atopic or eczematous dermatitis, psoriasis and / or&#xD;
             an active skin disease&#xD;
&#xD;
          -  Female subject is pregnant or lactating&#xD;
&#xD;
          -  Subject has any medical or psychiatric condition that, in the opinion of the&#xD;
             investigator, could jeopardize or would compromise the subject's wellbeing or ability&#xD;
             to participate in this study&#xD;
&#xD;
          -  Subject has a QTcB (QT interval corrected for heart rate according to Bazett's&#xD;
             formula) interval of ≥ 450 ms for female or ≥ 430 ms for male&#xD;
&#xD;
          -  Subject has a relevant hepatic dysfunction (total bilirubin &gt; 2 mg / dL or alanine&#xD;
             aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 2 times the&#xD;
             upper limit of the normal reference range)&#xD;
&#xD;
          -  Subject has tested positive for human immunodeficiency virus antibodies (HIV)-1 / 2Ab,&#xD;
             hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)&#xD;
&#xD;
          -  Subject has a positive urine drug screen and / or alcohol breath test on Day 1&#xD;
&#xD;
          -  Subject has made a blood donation or had a comparable blood loss (&gt; 400 mL)&#xD;
&#xD;
          -  Subject smokes or has done so within 6 months prior to Eligibility Assessment (EA)&#xD;
&#xD;
          -  Subject has a clinically relevant allergy&#xD;
&#xD;
          -  Subject is currently taking any medication&#xD;
&#xD;
          -  Female subject is currently taking an oral hormonal contraceptive&#xD;
&#xD;
          -  Subject has symptomatic orthostatic hypotension&#xD;
&#xD;
          -  Subject has a pulse rate at rest less than 45 beats per minute (bpm) or more than 100&#xD;
             bpm&#xD;
&#xD;
          -  Subject has a systolic blood pressure (SBP) lower than 100 mmHg or higher than 140&#xD;
             mmHg or diastolic blood pressure (DBP) higher than 90 mmHg&#xD;
&#xD;
          -  Subject has a current or a history of clinically relevant motor disturbance,&#xD;
             impairment of memory, sleep disturbance or neurodegenerative disease&#xD;
&#xD;
          -  Subject has consumed more than 3 cups (more than 450 ml) of caffeinated beverages per&#xD;
             day&#xD;
&#xD;
          -  Subject's abdomen is thickly covered with hair resulting in difficulties in finding&#xD;
             appropriate patch application sites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>December 3, 2012</last_update_submitted>
  <last_update_submitted_qc>December 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neupro, Pharmacokinetics, healthy Chinese subjects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotigotine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675024
org study id: SP0913
nct id: NCT01675024
lead sponsor: 
has dmc: No
This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine
      after single and multiple doses of Rotigotine transdermal patch, and also to investigate the
      safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
measure: Plasma concentrations of total Rotigotine for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Plasma concentrations of total Rotigotine for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
measure: Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC 0-tz) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Maximum plasma concentration (Cmax) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero to 24 hours at steady state (AUC(0-24h),ss) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Maximum plasma concentration at steady state (Cmax,ss) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Terminal half-life (t½) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1)
time frame: Period 1; Day1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Maximum plasma concentration normalized by Body Weight (kg) (Cmax, norm (BW)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Maximum plasma concentration normalized by apparent dose (mg)(Cmax, norm (apparent dose)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Maximum plasma concentration normalized by drug content of patch (mg) (Cmax, norm (mgdc)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-tz), norm (BW)) for single-dose application (Period 1)
time frame: Perion 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-tz), norm (apparent dose)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by drug content of patch (mg) (AUC(0-tz), norm (mgdc)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to infinity (AUC(0-∞)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-∞), norm (apparent dose)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-∞), norm (BW)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Area under the plasma concentration-time curve from zero up to infinity normalized by drug content of patch (mg) (AUC(0-∞), norm (mgdc)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Apparent total body clearance (CL/F) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Apparent volume of distribution (Vz/f) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Mean residence time (MRT) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Rate constant of elimination (ke) for single-dose application (Period 1)
time frame: Period 1; Day 1 to Day 3 of study
description: Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
measure: Terminal half-life (t½) for multiple-dose application
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
measure: Time to reach a maximum plasma concentration at steady state (tmax,ss) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Maximum plasma concentration at steady state normalized by body weight (kg) (Cmax,ss,norm(BW)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Maximum plasma concentration at steady state normalized by apparent dose (mg) (Cmax, ss, norm (apparent dose)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Maximum plasma concentration at steady state normalized by drug content of patch (mg) (Cmax, ss, norm (mgdc)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Minimum plasma concentration at steady state (Cmin, ss) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by body weight (kg) (AUC(0-24h), ss, norm (BW)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by apparent dose (mg) (AUC(0-24), ss, norm (apparent dose)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by drug content of patch (mg) (AUC(0-24), ss, norm (mgdc)) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
measure: Apparent total body clearance (CL/F) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Mean residence time (MRT) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Rate constant of elimination (ke) for multiple-dose application (Period 2)
time frame: Period 2; Day 7 to Day 14 of study
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
measure: Peak to trough fluctuation (PTF) for multiple-dose application (Period 2)
time frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
description: Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12.
arm group label: Rotigotine, Period 1
arm group type: Experimental
description: In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.
arm group label: Rotigotine, Period 2
arm group type: Experimental
description: In Period 2 (Day 7 to Day 14) all 24 subjects will receive 2 mg / 24 hours for 3 days then 4 mg / 24 hours for 3 days.
intervention type: Drug
intervention name: Rotigotine, Period 1
description: Formulation: transdermal
Dosage: 2 mg / 24 hours once at Day 2
Frequency: once every 24 hours
Duration: from Day 1 to Day 3
arm group label: Rotigotine, Period 1
other name: Neupro
intervention type: Drug
intervention name: Rotigotine, Period 2
description: Formulation: transdermal
Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12
Frequency: once every 24 hours
Duration: from Day 1 to Day 3
arm group label: Rotigotine, Period 2
other name: Neupro
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Rotigotine