<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/NCT02233777</url>
  </required_header>
  <id_info>
    <org_study_id>BE.293/EQL/2013</org_study_id>
    <nct_id>NCT02233777</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg</brief_title>
  <official_title>Bioequivalence Study of 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dexa Medica Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dexa Medica Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study was conducted to find out whether the bioavailability of 150 mg pregabalin&#xD;
      capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule&#xD;
      150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, open label, two-period, two-sequence, crossover study under fasting&#xD;
      condition. The participating subjects were required to have an overnight fast and in the next&#xD;
      morning were given orally one capsule of the test drug (Pregabalin 150 mg produced by Dexa&#xD;
      Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing&#xD;
      Deutschland GmbH, Germany).&#xD;
&#xD;
      Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and&#xD;
      1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36 hours after drug administration. Seven days after the&#xD;
      first drug administration (washout period), the procedure was repeated using the alternate&#xD;
      drug. The plasma concentrations of pregabalin were determined by using validated liquid&#xD;
      chromatography with tandem mass spectrometry detection (LC-MS/MS) method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCt</measure>
    <time_frame>36 hours</time_frame>
    <description>Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf</measure>
    <time_frame>36 hours</time_frame>
    <description>Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>36 hours</time_frame>
    <description>The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>36 hours</time_frame>
    <description>The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>T1/2</measure>
    <time_frame>36 hours</time_frame>
    <description>The elimination half life was determined from plasma concentrations of pregabalin from the test drug and reference drug.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pregabalin capsules 150 mg of Dexa Medica</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each capsule contains 150 mg pregabalin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each capsule contains 150 mg pregabalin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin capsules 150 mg of Dexa Medica</intervention_name>
    <description>Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.</description>
    <arm_group_label>Pregabalin capsules 150 mg of Dexa Medica</arm_group_label>
    <other_name>Test product: pregabalin capsules 150 mg of Dexa Medica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland</intervention_name>
    <description>Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.</description>
    <arm_group_label>Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland</arm_group_label>
    <other_name>Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, Germany</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with absence of significant disease or clinically significant&#xD;
             abnormal laboratory values or laboratory evaluation, medical history, or physical&#xD;
             examination during the screening and could be considered healthy based on the&#xD;
             evaluation&#xD;
&#xD;
          -  Aged 18-55 years inclusive&#xD;
&#xD;
          -  Preferably non-smokers or smoke less than 10 cigarettes per day&#xD;
&#xD;
          -  Able to participate, communicate well with the investigators and willing to provide&#xD;
             written informed consent to participate in the study&#xD;
&#xD;
          -  Body mass index within 18 to 25 kg/m2&#xD;
&#xD;
          -  Vital signs (after 10 minutes rest) within the following ranges:&#xD;
&#xD;
               -  Systolic blood pressure: 100-120 mmHg&#xD;
&#xD;
               -  Diastolic blood pressure: 60-80 mmHg&#xD;
&#xD;
               -  Pulse rate: 60-90 bpm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal/family history of allergy or hypersensitivity or contraindication to&#xD;
             pregabalin or allied drugs&#xD;
&#xD;
          -  Pregnant or lactating women (urinary pregnancy test was applied to women subjects at&#xD;
             screening and before taking the study drug)&#xD;
&#xD;
          -  Any major illnesses in the past 90 days or clinically significant ongoing chronic&#xD;
             medical illness e.g. congestive cardiac failure (heart failure), hepatitis,&#xD;
             hypotensive episodes, hyperglycemia, etc&#xD;
&#xD;
          -  Presence of any clinically significant abnormal values during screening, e.g.&#xD;
             significant abnormality of liver function test (ALT, alkaline phosphatase, total&#xD;
             bilirubin &gt;= 1.5 ULN), renal function test (serum creatinine concentration &gt; 1.4&#xD;
             mg/dL), etc&#xD;
&#xD;
          -  Positive hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV&#xD;
&#xD;
          -  Clinically significant electrocardiogram (ECG) abnormalities&#xD;
&#xD;
          -  Any surgical or medical condition (present or history) which might significantly alter&#xD;
             the absorption, distribution, metabolism, or excretion of the study drug, e.g.&#xD;
             gastrointestinal disease including gastric or duodenal ulcers or history of gastric&#xD;
             surgery&#xD;
&#xD;
          -  Past history of anaphylaxis or angiodema&#xD;
&#xD;
          -  History of drug or alcohol abuse within 12 months prior to screening for this study&#xD;
&#xD;
          -  Participation in any clinical trial within the past 90 days calculated from the last&#xD;
             visit&#xD;
&#xD;
          -  History of any bleeding or coagulative disorders&#xD;
&#xD;
          -  History of seizure, epilepsy, or any kind of neurological disorders&#xD;
&#xD;
          -  History of difficulty with donating blood or difficulty in accessibility of veins in&#xD;
             left or right arm&#xD;
&#xD;
          -  A donation or loss of 300 mL (or more) of blood within 3 months before this study's&#xD;
             first dosing day&#xD;
&#xD;
          -  Intake of any prescription, non-prescription drug, food supplements, or herbal&#xD;
             medicines within 14 days of this study's first dosing day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ratih SI Putri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PT Equilab International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PT Equilab International</name>
      <address>
        <city>Jakarta</city>
        <zip>12430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregabalin</keyword>
  <keyword>Bioequivalence</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Pharmacokinetic</keyword>
  <keyword>Antiepileptic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</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/NCT02233777
org study id: BE.293/EQL/2013
nct id: NCT02233777
lead sponsor: 
has dmc: No
The present study was conducted to find out whether the bioavailability of 150 mg pregabalin
      capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule
      150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).
This was a randomized, open label, two-period, two-sequence, crossover study under fasting
      condition. The participating subjects were required to have an overnight fast and in the next
      morning were given orally one capsule of the test drug (Pregabalin 150 mg produced by Dexa
      Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing
      Deutschland GmbH, Germany).

      Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and
      1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36 hours after drug administration. Seven days after the
      first drug administration (washout period), the procedure was repeated using the alternate
      drug. The plasma concentrations of pregabalin were determined by using validated liquid
      chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt
time frame: 36 hours
description: Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
measure: AUCinf
time frame: 36 hours
description: Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.
measure: Cmax
time frame: 36 hours
description: The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.
measure: Tmax
time frame: 36 hours
description: The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
measure: T1/2
time frame: 36 hours
description: The elimination half life was determined from plasma concentrations of pregabalin from the test drug and reference drug.
arm group label: Pregabalin capsules 150 mg of Dexa Medica
arm group type: Experimental
description: Each capsule contains 150 mg pregabalin.
arm group label: Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
arm group type: Active Comparator
description: Each capsule contains 150 mg pregabalin.
intervention type: Drug
intervention name: Pregabalin capsules 150 mg of Dexa Medica
description: Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
arm group label: Pregabalin capsules 150 mg of Dexa Medica
other name: Test product: pregabalin capsules 150 mg of Dexa Medica
intervention type: Drug
intervention name: Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
description: Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
arm group label: Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
other name: Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, Germany
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ratih SI Putri, MD
role: Principal Investigator
affiliation: PT Equilab International
facility: 
country: Indonesia
responsible party type: Sponsor
mesh term: Pregabalin