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OpenTrials
Completed

NCT Number: NCT00865176

Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eplerenone 50 mg Tablets Sandoz Inc., USA

Drug

Inspra 50 mg Tablets GD Searle LLC, USA

Drug

Primary outcomes

  1. Bioequivalence according to US FDA guidelines

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fasting Conditions.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 19, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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