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Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00865618
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA Drug: Inspra 50 mg Tablets GD Searle LLC, USA Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : June 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Eplerenone
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865618


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Deepen Patel, M.D., CCFP Allied Research International Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2009

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