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OpenTrials
Completed

NCT Number: NCT00960245

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

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

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Key information

Conditions

High Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Chest Pain Headache Disorders Headache Disorders, Primary Hypertension Migraine Disorders Migraine Headaches Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nadolol (1 x 80 mg) Tablets (Invamed, Inc)

Drug

Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
1994
Study completion
1994
First posted
Aug 17, 2009
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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