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
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

No publications provided

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
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents processed this record on April 22, 2014