[Translation] A randomized, open-label, fasting, single-dose, two-formulation, two-period, double-crossover bioequivalence study of sildenafil citrate orodisintegrating tablets in healthy adult Chinese subjects
研究空腹状态下单次口服受试制剂枸橼酸西地那非口崩片(规格:50 mg/片,由西施兰(南阳)药业股份有限公司生产,西施兰(南阳)药业股份有限公司提供)与枸橼酸西地那非口崩片(万艾可®,规格:50 mg/片;Pfizer Limited 持证,西施兰(南阳)药业股份有限公司提供)在健康成年受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
[Translation] The pharmacokinetics of the test preparations sildenafil citrate orodisintegrating tablets (specification: 50 mg/tablet, produced by Xishilan (Nanyang) Pharmaceutical Co., Ltd., provided by Xishilan (Nanyang) Pharmaceutical Co., Ltd.) and sildenafil citrate orodisintegrating tablets (Viagra®, specification: 50 mg/tablet; licensed by Pfizer Limited, provided by Xishilan (Nanyang) Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting state were studied, and the bioequivalence of the two preparations in the fasting state was evaluated.