[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, two-sequence crossover bioequivalence study of dolutegravir sodium tablets (50 mg) in healthy subjects under fasting and fed conditions
主要目的:以石家庄龙泽制药股份有限公司提供的多替拉韦钠片(50mg,以多替拉韦计)为受试制剂,按生物等效性试验的有关规定,与Glaxo Smithkline Pharmaceuticals SA生产的多替拉韦钠片(商品名:特威凯® ,Tivicay ®,规格:50mg,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂多替拉韦钠片和参比制剂多替拉韦钠片(特威凯® ,Tivicay ®)在健康受试者中的安全性。
[Translation] Main purpose: Dolutegravir sodium tablets (50 mg, calculated as dolutegravir) provided by Shijiazhuang Longze Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of dolutegravir sodium tablets (trade name: Tivicay®, specification: 50 mg, reference preparation) produced by Glaxo Smithkline Pharmaceuticals SA were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation dolutegravir sodium tablets and the reference preparation dolutegravir sodium tablets (Tivicay®, Tivicay®) in healthy subjects.