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Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00865176
First received: March 18, 2009
Last updated: March 27, 2017
Last verified: March 2009
March 18, 2009
March 27, 2017
June 2006
July 2006   (Final data collection date for primary outcome measure)
Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ]
Same as current
Complete list of historical versions of study NCT00865176 on ClinicalTrials.gov Archive Site
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Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions
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.
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Hypertension
  • Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
  • Drug: Inspra 50 mg Tablets GD Searle LLC, USA
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2006
July 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00865176
P1DX06002
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Deepen Patel, M.D., CCFP Allied Research International Inc.
Sandoz
March 2009

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