To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions

Overview

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.

Full Title of Study: “Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1994

Interventions

  • Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions
  • Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions
  • Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

Arms, Groups and Cohorts

  • Experimental: 1
    • Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions.
  • Experimental: 2
    • Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.
  • Active Comparator: 3
    • Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on AUC and Cmax
    • Time Frame: 53 days

Participating in This Clinical Trial

Inclusion Criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C. – Treatment for drug or alcohol dependence.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
  • Overall Official(s)
    • Richard Lalonde, Pharm.D., Principal Investigator, Phoenix International Life Science Inc.

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