<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/NCT01722201</url>
  </required_header>
  <id_info>
    <org_study_id>Ipca/ARL-12/126</org_study_id>
    <nct_id>NCT01722201</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition</brief_title>
  <official_title>A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Risperidone Tablet 1 mg With Risperdal® 1 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IPCA Laboratories Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IPCA Laboratories Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single&#xD;
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence&#xD;
      between Test Product and the corresponding Reference Product under fasting condition in&#xD;
      normal, healthy, adult human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective of this pivotal study was to assess the bioequivalence between Test Product:&#xD;
      Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference&#xD;
      Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under&#xD;
      fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.&#xD;
&#xD;
      The study was conducted with 48 healthy adult subjects. In each study period, a single 1 mg&#xD;
      dose of either test or reference was administered to the subjects as per the randomization&#xD;
      schedule in each study period with about 240 mL of water at ambient temperature in sitting&#xD;
      position.&#xD;
&#xD;
      The duration of the clinical phase was approximately 16 days including washout period of at&#xD;
      least 10 days between administrations of study drug in each study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioequivalence is based on Cmax and AUC parameters.</measure>
    <time_frame>3 months</time_frame>
    <description>Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post-dose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Fasting</condition>
  <arm_group>
    <arm_group_label>Risperidone Tablet 1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Risperidone Tablet 1 mg of M/s Ipca Laboratories Limited, India</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risperdal®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Risperdal® (Risperidone) Tablet 1 mg of Janssen Pharmaceutica Products, USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone Tablet 1 mg</intervention_name>
    <description>1 mg tablet once a day</description>
    <arm_group_label>Risperidone Tablet 1 mg</arm_group_label>
    <other_name>Test Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone</intervention_name>
    <description>1 mg tablet once a day</description>
    <arm_group_label>Risperdal®</arm_group_label>
    <other_name>Risperdal®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and non-female human subjects, age in the range of 18 - 45 years (both&#xD;
             inclusive).&#xD;
&#xD;
          2. Body weight within ± 15% of ideal weight as related to height and body frame according&#xD;
             to Life Insurance Corporation (LIC) Chart.&#xD;
&#xD;
          3. Subjects with normal findings as determined by baseline history, physical examination&#xD;
             and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).&#xD;
&#xD;
          4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,&#xD;
             serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray&#xD;
             (chest X-ray if required).&#xD;
&#xD;
          5. Willingness to follow the protocol requirements as evidenced by written informed&#xD;
             consent.&#xD;
&#xD;
          6. Subject willing to give written informed consent.&#xD;
&#xD;
          7. Confirming and agreeing to, not using any prescription and over the counter&#xD;
             medications including vitamins and minerals for 14 days prior to study and during the&#xD;
             course of the study.&#xD;
&#xD;
          8. No history of drug abuse in the past one year.&#xD;
&#xD;
          9. Non-smokers and non-alcoholics.&#xD;
&#xD;
         10. For female subject&#xD;
&#xD;
               -  is child bearing potential practicing acceptable method of birth control for the&#xD;
                  duration of the study as judged by Investigator such as Condom, Foams,&#xD;
                  Jellies,Diaphragm, Intrauterine device and Abstinence OR&#xD;
&#xD;
               -  is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or&#xD;
                  hysterectomy has been performed on the subject).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known history of hypersensitivity to Risperidone, or related drugs.&#xD;
&#xD;
          2. Requiring medication for any ailment having enzyme-modifying activity in the previous&#xD;
             28 days, prior to dosing day.&#xD;
&#xD;
          3. Any medical or surgical conditions, which might significantly interfere with the&#xD;
             functioning of gastrointestinal tract, blood-forming organs etc.&#xD;
&#xD;
          4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,&#xD;
             metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric&#xD;
             diseases and bleeding tendency.&#xD;
&#xD;
          5. Participation in a clinical drug study or bioequivalence study within 90 days prior to&#xD;
             present study.&#xD;
&#xD;
          6. History of malignancy or other serious diseases.&#xD;
&#xD;
          7. Refusal to abstain from food for at least ten (10.00) hours prior to receiving the&#xD;
             high-fat and high-calorie breakfast and for at least four (04.00) additional hours&#xD;
             post-dose in each study period.&#xD;
&#xD;
          8. Any contraindication to blood sampling or difficulty in accessibility of veins.&#xD;
&#xD;
          9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug&#xD;
             administration and for at least 01.00 additional hour post-dose, in each study period&#xD;
             except about 240 mL of water given during administration of study drug.&#xD;
&#xD;
         10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea,&#xD;
             coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for&#xD;
             48.00 hours prior to dosing until the last blood sample collection of last study&#xD;
             period.&#xD;
&#xD;
         11. Blood donation within 90 days prior to the commencement of the study.&#xD;
&#xD;
         12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.&#xD;
&#xD;
         13. Found positive in breath alcohol test done before check-in for each study period.&#xD;
&#xD;
         14. Found positive in urine test for drugs of abuse done before check-in for each study&#xD;
             period.&#xD;
&#xD;
         15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing&#xD;
             until the last blood sample collection of last study period.&#xD;
&#xD;
         16. History of problem in swallowing Tablet(s).&#xD;
&#xD;
         17. Female subject, demonstrating positive urine pregnancy test at the time of screening.&#xD;
&#xD;
         18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic&#xD;
             Gonadotropin) test before check-in for each study period.&#xD;
&#xD;
         19. Female subject, currently breast feeding or lactating.&#xD;
&#xD;
         20. Female subjects not willing to use acceptable method of contraception from the date of&#xD;
             screening until the completion of the study.&#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>
  <overall_official>
    <last_name>Dr. Tarang Shah, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Accutest Research Lab (I) Pvt. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Accutest Research Lab (I) Pvt. Ltd.</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 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>Risperidone</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/NCT01722201
org study id: Ipca/ARL-12/126
nct id: NCT01722201
lead sponsor: 
has dmc: Yes
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under
      fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 1 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 16 days including washout period of at
      least 10 days between administrations of study drug in each study period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioequivalence is based on Cmax and AUC parameters.
time frame: 3 months
description: Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post-dose.
arm group label: Risperidone Tablet 1 mg
arm group type: Experimental
description: Risperidone Tablet 1 mg of M/s Ipca Laboratories Limited, India
arm group label: Risperdal®
arm group type: Active Comparator
description: Risperdal® (Risperidone) Tablet 1 mg of Janssen Pharmaceutica Products, USA
intervention type: Drug
intervention name: Risperidone Tablet 1 mg
description: 1 mg tablet once a day
arm group label: Risperidone Tablet 1 mg
other name: Test Product
intervention type: Drug
intervention name: Risperidone
description: 1 mg tablet once a day
arm group label: Risperdal®
other name: Risperdal®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Tarang Shah, M.D.
role: Principal Investigator
affiliation: Accutest Research Lab (I) Pvt. Ltd.
facility: 
country: India
responsible party type: Sponsor
mesh term: Risperidone