To Demonstrate the Relative Bioavailability of Atenolol Tablets
Overview
To demonstrate the relative bioavailability of Atenolol tablets.
Full Title of Study: “Bioavailability of Atenolol Tablets”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 1989
Interventions
- Drug: Atenolol Tablets 100 mg (Cord Laboratories)
- Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)
Arms, Groups and Cohorts
- Experimental: 1
- Atenolol Tablets 100 mg (Cord Laboratories)
- Active Comparator: 2
- Atenolol Tablets 100 mg (Stuart Pharmaceutical)
Clinical Trial Outcome Measures
Primary Measures
- Bioequivalence based on AUC and Cmax
- Time Frame: 11 days
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 19 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Sandoz
- Provider of Information About this Clinical Study
- Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
- Overall Official(s)
- Rudolph C. Cane, Jr., M.D., Principal Investigator, PharmaKinetics Laboratories Inc.
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