Clinical Trials Directory

Trials / Completed

CompletedNCT00865176

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.

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Sandoz · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.

Conditions

Interventions

TypeNameDescription
DRUGEplerenone 50 mg Tablets Sandoz Inc., USA
DRUGInspra 50 mg Tablets GD Searle LLC, USA

Timeline

Start date
2006-06-01
Primary completion
2006-07-01
Completion
2006-07-01
First posted
2009-03-19
Last updated
2017-03-29

Source: ClinicalTrials.gov record NCT00865176. Inclusion in this directory is not an endorsement.