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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00960245
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions.
Study Start Date : July 1994
Primary Completion Date : July 1994
Study Completion Date : July 1994

Resource links provided by the National Library of Medicine

Drug Information available for: Nadolol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 21 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960245


Sponsors and Collaborators
Sandoz
Investigators
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.
ClinicalTrials.gov Identifier: NCT00960245     History of Changes
Other Study ID Numbers: PRACS P94-102
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: August 2009

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