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NCT00946725 Clinical Trial

To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

Hypertension Clinical Trial

Official title:
A Comparative Bioavailability Study of Atenolol Tablets, 100 mg

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00946725
Other study ID # 11627
Secondary ID
Status Completed
Phase Phase 1
First received July 24, 2009
Last updated March 27, 2017
Start date November 2000
Est. completion date November 2000

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

Clinical Trial Summary

To demonstrate the relative bioavailability of atenolol tablets, 100 mg.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 2000
Est. primary completion date November 2000
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 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:
• Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)

• Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)

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 20 days
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