To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT00913822

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories) Drug: Norpramin 100 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:

Bioavailability of Desipramine Hydrochloride Tablets

Study Start Date :

Dec 1, 1987

Actual Primary Completion Date :

Dec 1, 1987

Actual Study Completion Date :

Dec 1, 1987

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)	Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
Active Comparator: 2 Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)	Drug: Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Arm

Intervention/Treatment

Experimental: 1

Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)

Drug: Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)

Active Comparator: 2

Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Drug: Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Outcome Measures

Primary Outcome Measures

Bioequivalence based on AUC and Cmax [22 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 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., University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00913822

Other Study ID Numbers:

870609D

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