Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

Sandoz60 enrolled

Overview

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Eplerenone 50 mg Tablets Sandoz Inc., USADRUG

Inspra 50 mg Tablets GD Searle LLC, USADRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence according to US FDA guidelines

Time frame: 10 days

Data from ClinicalTrials.gov

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