To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc; Drug: Desipramine HCL 100 mg Tablets Cord Laboratories

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913809

870609-D

Details and patient eligibility

About

To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

Desipramine HCL 100 mg Tablets Cord Laboratories

Treatment:

Drug: Desipramine HCL 100 mg Tablets Cord Laboratories

2

Active Comparator group

Description:

Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc

Treatment:

Drug: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc