Healthy Clinical Trial
Official title:
Comparative, Randomized, Two-period, Two-treatment, Two-sequence, Single Dose, Open-label, Crossover Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET (One Tablet) of (Sanovel İlaç San. ve Tic. A.Ş., İstanbul / Türkiye) Versus ANTADYS® Flurbiprofen 100 mg Comprimé Pelliculé (One Film-coated Tablet) of (LaboratoireThẻramex 6, Avenue Albert II- BP.59 98007 MONACO Cedex) and PEPCID® (Famotidine) 20 mg Tablets, USP (One Tablet) of (Marathon Pharmaceuticals, LLC USA) in Healthy Subjects Under Fasting Conditions
To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID® (Famotidine) 20mg Tablets, USP.
An open-label, randomized, single dose, two-treatment, two-period, two-sequence, crossover bioequivalence with a washout period of at least 7 days between doses Healthy mixed skin Arab & Mediterranean Subjects ages between 18 and 45 years, body-mass index 18.5 to 30.0 kg/m2 inclusive, non-smokers or light smokers (smokers of not more than 10 cigarettes per day). ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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