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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

Page last updated: August 23, 2015

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