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

Phase 1

Completed

• Conditions: Depression
• 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

• Registration Number: NCT00913952
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1994-04
• Primary Completion: 1994-06
• Study Completion: 1994-06
• 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: 18

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	Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions	Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions.
2	Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions	Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.
3	Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions	Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	53 days