Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Eplerenone 50 mg Tablets Sandoz Inc., USA (Drug); Inspra 50 mg Tablets GD Searle LLC, USA (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s): Deepen Patel, M.D., CCFP, Principal Investigator, Affiliation: Allied Research International Inc.
Summary
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg
ER Tablets under fasting conditions.
Clinical Details
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 Fasting Conditions.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence according to US FDA guidelines
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 2006
Last updated: March 18, 2009
|