[Translation] A single-center, randomized, open-label, three-period, three-crossover, single-dose oral administration trial to evaluate the bioequivalence of emtricitabine and tenofovir alafenamide tablets (II) in healthy Chinese adults under fasting and fed conditions
主要目的: 以华北制药华坤河北生物技术有限公司提供的恩曲他滨丙酚替诺福韦片(Ⅱ)(恩曲他滨200mg与丙酚替诺福韦25mg)为受试制剂,按有关生物等效性研究的规定,与Patheon Inc.(持证商:Gilead Sciences Ireland UC)生产的恩曲他滨丙酚替诺福韦片(Ⅱ)(恩曲他滨200mg与丙酚替诺福韦25mg)(商品名:DESCOVY®)参比制剂在中国健康成人受试者中,比较吸收程度和吸收速度的差异,考察两制剂的生物等效性。
次要目的:观察受试制剂恩曲他滨丙酚替诺福韦片(Ⅱ)和参比制剂恩曲他滨丙酚替诺福韦片(Ⅱ)(DESCOVY®)在中国健康成人受试者中的安全性和耐受性。
[Translation] Main objective: To compare the differences in absorption extent and absorption rate between the test preparation and the reference preparation of emtricitabine and tenofovir alafenamide tablets (II) (emtricitabine 200 mg and tenofovir alafenamide 25 mg) (trade name: DESCOVY®) produced by Patheon Inc. (license holder: Gilead Sciences Ireland UC) in healthy Chinese adult subjects, and to investigate the bioequivalence of the two preparations.
Secondary objective: To observe the safety and tolerability of the test preparation emtricitabine and tenofovir alafenamide tablets (II) and the reference preparation emtricitabine and tenofovir alafenamide tablets (II) (DESCOVY®) in healthy Chinese adult subjects according to the provisions of relevant bioequivalence studies.