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: NA
Last verified: March 2009
History: No changes posted

March 18, 2009
March 18, 2009
June 2006
July 2006   (final data collection date for primary outcome measure)
Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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
Not Provided

*   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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00865176
P1DX06002
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
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