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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