Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions
Overview
The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.
Full Title of Study: “A Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 1994
Interventions
- Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
- Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Arms, Groups and Cohorts
- Experimental: 1
- Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
- Active Comparator: 2
- Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Clinical Trial Outcome Measures
Primary Measures
- Bioequivalence based on AUC and Cmax
- Time Frame: 21 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: 18 Years
Maximum Age: 40 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)
- Terry L. Wolff, D.O., Principal Investigator, MeritCare Broadway Health Center
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