To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

Phase 1

Completed

• Conditions: Hypertension; Angina
• Interventions: Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical); Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)

• Registration Number: NCT00946725
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2000-11
• Study Completion: 2000-11
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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
2	Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)	Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
1	Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)	Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	20 days