Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Inspra 50 mg Tablets GD Searle LLC, USA; Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00865618

P1DX06003

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Eplerenone 50mg Tablets

Treatment:

Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA

2

Active Comparator group

Description:

INSPRA 50mg Tablets

Treatment:

Drug: Inspra 50 mg Tablets GD Searle LLC, USA