To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: 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 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s):
Richard Lalonde, Pharm.D., Principal Investigator, Affiliation: Phoenix International Life Science Inc.
Summary
To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg
Clomipramine Hydrochloride capsules under fed and fasted conditions.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 1994
Last updated: June 3, 2009
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