Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.

Condition Intervention Phase
Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
Drug: Inspra 50 mg Tablets GD Searle LLC, USA
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Eplerenone 50mg Tablets
Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
Active Comparator: 2
INSPRA 50mg Tablets
Drug: Inspra 50 mg Tablets GD Searle LLC, USA


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00865176

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Deepen Patel, M.D., CCFP Allied Research International Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00865176     History of Changes
Other Study ID Numbers: P1DX06002 
Study First Received: March 18, 2009
Last Updated: March 18, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 25, 2016