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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
 (submitted: March 18, 2009)
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
 (submitted: March 18, 2009)
60
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