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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals); Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

• Registration Number: NCT00913783
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1992-11
• Primary Completion: 1992-12
• Study Completion: 1992-12
• Status Verified: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)	Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)
2	Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)	Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	34 days