Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

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	Complete list of historical versions of study NCT00865176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	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	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