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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