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

Sandoz36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Desipramine HCL 100 mg Tablets Cord LaboratoriesDRUG

Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, IncDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 24 days

Data from ClinicalTrials.gov

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