Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00865618

First received: March 18, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Purpose

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

Condition	Intervention	Phase
Hypertension	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 Fed Conditions.

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Drug Information available for: Eplerenone

U.S. FDA Resources

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

Eligibility


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

Criteria

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 ClinicalTrials.gov identifier: NCT00865618

Sponsors and Collaborators

Sandoz

Investigators


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.
ClinicalTrials.gov Identifier:	NCT00865618 History of Changes
Other Study ID Numbers:	P1DX06003
Study First Received:	March 18, 2009
Last Updated:	March 18, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Eplerenone Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents

ClinicalTrials.gov processed this record on September 29, 2016

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