Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: August 13, 2009
Last updated: August 14, 2009
Last verified: August 2009
The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.

Condition Intervention Phase
High Blood Pressure
Migraine Headaches
Chest Pain
Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions.

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: July 1994
Study Completion Date: July 1994
Primary Completion Date: July 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Active Comparator: 2
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00960245

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Terry L. Wolff, D.O. MeritCare Broadway Health Center
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00960245     History of Changes
Other Study ID Numbers: PRACS P94-102 
Study First Received: August 13, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Migraine Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympatholytics processed this record on May 26, 2016