Overview

Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers

Status:
Completed
Trial end date:
2022-05-31
Target enrollment:
Participant gender:
Summary
This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and Reference medicinal product (marketed medicinal product NurofenĀ® Forte Express, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by Reckitt Benckiser [Poland] S.A.) in healthy volunteers.
Phase:
Phase 1
Details
Lead Sponsor:
Darnitsa Pharmaceutical Company
Collaborator:
ACDIMA Biocenter
Treatments:
Ibuprofen