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First received: December 15, 2022

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

Study Status: Completed

Recruit Status: Completed

Condition: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Co

Study Type: Interventional


Official Title: Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Efez 50 mg Eplerenone Film-coated Tablets Versus INSPRA® 50 mg Eplerenone Film-coated Tablets,

Brief 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.

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