Overview

Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers

Status:
Completed
Trial end date:
2021-12-28
Target enrollment:
Participant gender:
Summary
This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.
Phase:
Phase 1
Details
Lead Sponsor:
Darnitsa Pharmaceutical Company
Collaborator:
ACDIMA Biocenter
Treatments:
Eplerenone