Comment:Inclusion criteria included wholesome nonsmoking (for at least 6 months before first drug administration) males, _18 years of age with a physique mass index between _18.5 and _29.9 kg/m2, systolic blood pressure (BP) between _100 and _140 mm Hg, diastolic BP between _60 and _90 mm Hg, heart price (HR) between _50 and _100 beats per minute, and decided to be in good well being by medical historical past, bodily examination, important signs, laboratory outcomes, and electrocardiogram. The pharmacokinetic performance of each product was studied using a crossover design with 18 wholesome, nonsmoking (for at least 6 months before first drug administration) male volunteers. A randomized single-dose research was conducted in healthy, nonsmoking male volunteers under fasting situations to assess the bioequivalency of two sildenafil OSF 100 mg formulations (MonoSol Rx, LLC) as compared with sildenafil citrate 100 mg tablets. Every topic was administered an oral dose of 1 × sildenafil OSF one hundred mg, the alternative sildenafil OSF one hundred mg, or 1 × sildenafil citrate a hundred mg tablet below fasting circumstances. The clinical study was designed as a pilot, single-dose, randomized, open-label, 3-interval, 6-sequence, 3-therapy, single-heart, crossover, comparative bioavailability study of 2 formulations of sildenafil OSF one hundred mg and sildenafil citrate a hundred mg tablets.
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