To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.
Full Title of Study: “Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 1990
- Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
- Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
Arms, Groups and Cohorts
- Experimental: 1
- Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
- Experimental: 2
- Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
Clinical Trial Outcome Measures
- Bioequivalence based on AUC and Cmax
- Time Frame: 19 days
Participating in This Clinical Trial
- 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.
Gender Eligibility: Male
Minimum Age: 19 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Provider of Information About this Clinical Study
- Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
- Overall Official(s)
- James C. Kisicki, M.D., Principal Investigator, Harris Laboratories, Incorporated
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