To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

• Sponsor: Sandoz (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00913237
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories); Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets
• Study Start Date: Jul 1, 1987
• Actual Primary Completion Date: Aug 1, 1987
• Actual Study Completion Date: Aug 1, 1987

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)	Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
Active Comparator: 2 Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)	Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)

Outcome Measures

Primary Outcome Measures

1. Bioequivalence based on AUC and Cmax [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sandoz

Investigators

• Principal Investigator: Jules Kann, M.D., Biodecision Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00913237
• Other Study ID Numbers: 860520D
• First Posted: Jun 4, 2009
• Last Update Posted: Mar 28, 2017
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Antidepressant
• Additional relevant MeSH terms: Depression; Desipramine

Study Results

No Results Posted as of Mar 28, 2017