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NCT00960245 Clinical Trial

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

Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00960245
Other study ID # PRACS P94-102
Secondary ID
Status Completed
Phase Phase 1
First received August 13, 2009
Last updated March 27, 2017
Start date July 1994
Est. completion date July 1994

Study information
Verified date August 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date July 1994
Est. primary completion date July 1994
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nadolol (1 x 80 mg) Tablets (Invamed, Inc)

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 21 days
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