To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories); Drug: Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

• Registration Number: NCT00913822
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 1987-12
• Primary Completion: 1987-12
• Study Completion: 1987-12
• 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	Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)	Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
2	Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)	Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	22 days