A randomized, open-label 3-way crossover study to investigate the relative bioavailability and bioequivalence of crushed sildenafil 20 mg tablets mixed with apple sauce, extemporaneously prepared suspension (EP), and intact sildenafil 20 mg tablets in healthy volunteers under fasting conditions.

摘要: The relative bioavailability and bioequivalence of 20-mg doses a pediatric formulation sildenafil extemporaneous preparation suspension (EP; 10 mg/mL), the intact tablet crushed mixed with apple sauce were assessed in single-dose, randomized, open-label, 3-way crossover study 18 healthy adult volunteers. Blood samples collected at predefined times analyzed for plasma concentrations. Natural log-transformed pharmacokinetic parameters (Cmax , AUClast AUCinf ) used to estimate construct 90% confidence intervals (CI) using mixed-effects model. Bioequivalence was concluded among three formulations one exception, which EP showed 15% decrease Cmax lower CI 76% compared tablet. is not considered be clinically relevant. Therefore, an appropriate formulation. All 3 well tolerated