To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Desipramine HCL 100 mg Tablets Cord Laboratories (Drug); Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s):
Jules Kann, Ph.D., Principal Investigator, Affiliation: Biodecision Laboratories
Summary
To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to
Merrell Dow's 100 mg Norpramin tablets.
Clinical Details
Official title: A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: December 1987
Last updated: June 3, 2009
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