To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Phase 1
Completed
- Conditions
- Depression
- Interventions
- Registration Number
- NCT00913809
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.
- Detailed Description
Not available
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 HCL 100 mg Tablets Cord Laboratories Desipramine HCL 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 24 days
- Secondary Outcome Measures
Name Time Method