Back to resultsComparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Eplerenone 50 mg Tablets Sandoz Inc., USA
Inspra 50 mg Tablets GD Searle LLC, USA
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Eplerenone 50mg Tablets
INSPRA 50mg Tablets
Outcomes
Primary Outcome Measures
Bioequivalence according to US FDA guidelines
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00865618
Brief Title
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Eplerenone 50mg Tablets
Arm Title
2
Arm Type
Active Comparator
Arm Description
INSPRA 50mg Tablets
Intervention Type
Drug
Intervention Name(s)
Eplerenone 50 mg Tablets Sandoz Inc., USA
Intervention Type
Drug
Intervention Name(s)
Inspra 50 mg Tablets GD Searle LLC, USA
Primary Outcome Measure Information:
Title
Bioequivalence according to US FDA guidelines
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepen Patel, M.D., CCFP
Organizational Affiliation
Allied Research International Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
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