Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00865176

Recruitment Status : Completed

First Posted : March 19, 2009

Last Update Posted : March 29, 2017

Sponsor:

Information provided by:

Sandoz

Tracking Information

First Submitted Date ^ICMJE

March 18, 2009

First Posted Date ^ICMJE

March 19, 2009

Last Update Posted Date

March 29, 2017

Study Start Date ^ICMJE

June 2006

Actual Primary Completion Date

July 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: 1
Eplerenone 50mg Tablets

Intervention: Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
Active Comparator: 2
INSPRA 50mg Tablets

Intervention: Drug: Inspra 50 mg Tablets GD Searle LLC, USA

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Actual Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

July 2006

Actual Primary Completion Date

July 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00865176

Other Study ID Numbers ^ICMJE

P1DX06002

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Deepen Patel, M.D., CCFP

Allied Research International Inc.

PRS Account

Sandoz

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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