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First received: December 15, 2022

Clinical Trial: Bioequivalence Study of Test and Reference 400 mg Ibuprofen 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 Darfen 400, 400 mg Ibuprofen Coated Tablets (512 mg Ibuprofen Sodium Dihydrate) Versus Nurofen

Brief 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 Nurofen® Forte Express, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by Reckitt Benckiser [Poland] S.A.) in healthy volunteers.

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