Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA; Drug: Inspra 50 mg Tablets GD Searle LLC, USA

• Registration Number: NCT00865618
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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	Eplerenone 50 mg Tablets Sandoz Inc., USA	Eplerenone 50mg Tablets
2	Inspra 50 mg Tablets GD Searle LLC, USA	INSPRA 50mg Tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines	10 days