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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: March 27, 2017
Last verified: March 2009
  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
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.

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 ]

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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 27, 2017

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 August 23, 2017