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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00960245
First received: August 13, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960245

Sponsors and Collaborators
Sandoz Inc.
Investigators
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.
ClinicalTrials.gov 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
Headache
Hypertension
Migraine Disorders
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 15, 2014