To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.); Drug: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

• Registration Number: NCT00946764
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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	Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)	Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
2	Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)	Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	41 days