To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 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 50 mg Tablets Cord Laboratories (Drug); Norpramin 50 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 comparing single 100 mg doses Of Cord's 50 mg
Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.
Clinical Details
Official title: A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 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: 40 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
Last updated: June 3, 2009
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