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

Phase 1

Completed

• Conditions: High Blood Pressure; Migraine Headaches; Chest Pain
• Interventions: Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc); Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

• Registration Number: NCT00960245
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1994-07
• Primary Completion: 1994-07
• Study Completion: 1994-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Nadolol (1 x 80 mg) Tablets (Invamed, Inc)	Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
2	Corgard (1 x 80 mg) Tablets (Bristol Laboratories)	Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	21 days