NCT05663372

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

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, in Healthy Adult Male and Female Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Darnitsa Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Efez 50 mg eplerenone film-coated tablets	Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone
DRUG	INSPRA® 50 mg eplerenone film-coated tablets	Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone

Timeline

• Start date: 2021-12-07
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: Jordan