<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/NCT01712568</url>
  </required_header>
  <id_info>
    <org_study_id>SLL/RPR/1117/08</org_study_id>
    <nct_id>NCT01712568</nct_id>
  </id_info>
  <brief_title>Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets</brief_title>
  <official_title>AN OPEN LABEL, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, BIOEQUIVALENCE STUDY OF ROPINIROLE HYDROCHLORIDE CR 2mg TABLETS OF LUPIN LIMITED, INDIA, COMPARING WITH THAT OF REQUIP XL OF GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, IN HEALTHY ADULT MALE SUBJECTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lupin Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lupin Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study subjects were screened and enrolled for the study. Subjects were housed in the clinical&#xD;
      facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each&#xD;
      period. After maintaining at least 10 hours of overnight fast Test or Reference product was&#xD;
      administered orally (as per the randomization schedule) to each subject with about 240 mL of&#xD;
      water at ambient temperature in each period by trained study personnel.&#xD;
&#xD;
      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were&#xD;
      collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,&#xD;
      10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period&#xD;
      with a washout period of 7 days between the dosing of two periods. Subjects were continuously&#xD;
      monitored for well being i.e., blood pressure, radial pulse and oral temperature before&#xD;
      check-in, prior to drug administration and at regular intervals post dose in each period. The&#xD;
      concentration of Ropinirole in plasma samples obtained from study subjects was determined&#xD;
      using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on&#xD;
      obtained drug concentration data, using appropriate software.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">October 2008</completion_date>
  <primary_completion_date type="Actual">September 2008</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the pharmacokinetic (PK) profile for Ropinirole in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.</measure>
    <time_frame>Predose, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations and electrocardiograms</measure>
    <time_frame>From baseline day 0 through to post study Follow-up (maximum 20 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pharmacokinetic Study</condition>
  <arm_group>
    <arm_group_label>Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Ropinirole Single oral dose of Ropinirole hydrochloride CR 2mg Tablets under fasting conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Ropinirole REQUIP XL Tablets (Ropinirole hydrochloride CR 2mg)commercial formulation under fasting conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test Product (Ropinirole)</intervention_name>
    <description>one Tablet at &quot;0&quot; hour</description>
    <arm_group_label>Reference Product</arm_group_label>
    <arm_group_label>Test Product</arm_group_label>
    <other_name>Ropinirole HCl Tablets CR 2mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reference Product (REQUIP )</intervention_name>
    <description>one Tablet at &quot;0&quot; hour</description>
    <arm_group_label>Reference Product</arm_group_label>
    <arm_group_label>Test Product</arm_group_label>
    <other_name>REQUIP XL Tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i. Availability of volunteer for the entire study period and willingness to adhere to&#xD;
        protocol requirements as evidenced by the written informed consent form (ICF) duly signed&#xD;
        by the volunteer.&#xD;
&#xD;
        ii. Healthy human male subjects between 18-45 years Weighing at least 50 kg and with a body&#xD;
        mass index (BMI) of 18 kg/m2 and less than or equal to 25 kg/m2 (according to the formula&#xD;
        of BMI = weight (kg)/[height (m)]2).&#xD;
&#xD;
        iii. Subjects who have no evidence of underlying disease during screening medical history&#xD;
        and whose physical examination is performed within 14 days prior to commencement of the&#xD;
        study.&#xD;
&#xD;
        iv. Subjects whose screening laboratory values are within normal limits or considered by&#xD;
        the physician/Principal Investigator to be of no clinical significance.&#xD;
&#xD;
        v. Light-, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes&#xD;
        or less per day, and ex-smokers are defined as someone who completely stopped smoking for&#xD;
        at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History or presence of significant:&#xD;
&#xD;
        I. History of hypersensitivity or idiosyncratic reactions to Ropinirole or any related&#xD;
        products.&#xD;
&#xD;
        II. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,&#xD;
        immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.&#xD;
&#xD;
        III. Alcohol dependence, alcohol abuse or drug abuse within past one year. IV. Moderate to&#xD;
        heavy smoking (&gt;10 cigarettes/day) or consumption of tobacco products.&#xD;
&#xD;
        V. History of difficulty in swallowing VI. Clinically significant illness within 4 weeks&#xD;
        before the start of the study VII. Asthma, urticaria or other allergic type reactions after&#xD;
        taking any medication.&#xD;
&#xD;
        Blood loss/donation of more than 350 mL within 3 months prior to study dosing or difficulty&#xD;
        in donating blood.&#xD;
&#xD;
        Participation in another clinical study not involving donation of blood, within the&#xD;
        preceding 90 days of study start.&#xD;
&#xD;
        Subjects who have:&#xD;
&#xD;
        i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg&#xD;
&#xD;
        ii. Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor&#xD;
        deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician&#xD;
        /investigator.&#xD;
&#xD;
        iii. Pulse rate below 50/min. or above 105/min.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satyanarayana V, M.Pharma., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sipra Labs Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sipra Labs Limited</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500 038</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropinirole</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/NCT01712568
org study id: SLL/RPR/1117/08
nct id: NCT01712568
lead sponsor: 
has dmc: Yes
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical
      facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each
      period. After maintaining at least 10 hours of overnight fast Test or Reference product was
      administered orally (as per the randomization schedule) to each subject with about 240 mL of
      water at ambient temperature in each period by trained study personnel.

      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were
      collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,
      10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period
      with a washout period of 7 days between the dosing of two periods. Subjects were continuously
      monitored for well being i.e., blood pressure, radial pulse and oral temperature before
      check-in, prior to drug administration and at regular intervals post dose in each period. The
      concentration of Ropinirole in plasma samples obtained from study subjects was determined
      using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on
      obtained drug concentration data, using appropriate software.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Description of the pharmacokinetic (PK) profile for Ropinirole in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
time frame: Predose, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours
measure: Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations and electrocardiograms
time frame: From baseline day 0 through to post study Follow-up (maximum 20 days)
arm group label: Test Product
arm group type: Experimental
description: Drug: Ropinirole Single oral dose of Ropinirole hydrochloride CR 2mg Tablets under fasting conditions
arm group label: Reference Product
arm group type: Experimental
description: Drug: Ropinirole REQUIP XL Tablets (Ropinirole hydrochloride CR 2mg)commercial formulation under fasting conditions
intervention type: Drug
intervention name: Test Product (Ropinirole)
description: one Tablet at "0" hour
arm group label: Reference Product
arm group label: Test Product
other name: Ropinirole HCl Tablets CR 2mg
intervention type: Drug
intervention name: Reference Product (REQUIP )
description: one Tablet at "0" hour
arm group label: Reference Product
arm group label: Test Product
other name: REQUIP XL Tablets
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Satyanarayana V, M.Pharma., Ph.D
role: Principal Investigator
affiliation: Sipra Labs Limited
facility: 
country: India
responsible party type: Sponsor
mesh term: Ropinirole