磷丙替诺福韦片在健康受试者中空腹和餐后给药的生物等效性试验
[Translation] Bioequivalence study of tenofovir fosprenovir tablets in healthy volunteers after fasting and feeding
主要研究目的
研究中国健康受试者在空腹和餐后条件下单次口服受试制剂磷丙替诺福韦片25mg与参比制剂磷丙替诺福韦片(Vemlidy®)25mg的药代动力学行为,评价空腹和餐后条件下口服两种制剂的生物等效性。
次要研究目的
评价受试制剂磷丙替诺福韦片25mg与参比制剂磷丙替诺福韦片(Vemlidy®)25mg在健康人群中的安全性。
[Translation] Main study objectives
To study the pharmacokinetic behavior of the test preparation fospropin tenofovir tablets 25 mg and the reference preparation fospropin tenofovir tablets (Vemlidy®) 25 mg in Chinese healthy subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions.
Secondary study objectives
To evaluate the safety of the test preparation fospropin tenofovir tablets 25 mg and the reference preparation fospropin tenofovir tablets (Vemlidy®) 25 mg in healthy people.
/ CompletedNot Applicable 评价那屈肝素钙注射液在中国成年健康受试者中的一项单中心、随机、开放、空腹条件下单次给药、两制剂、两周期交叉的生物等效性研究
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of nadroparin calcium injection in healthy adult Chinese subjects under fasting conditions
主要研究目的:
考察单次注射受试制剂那屈肝素钙注射液和参比制剂那屈肝素钙注射液,在中国成年健康受试者体内的药效学特征,评估两种制剂的生物等效性。
次要研究目的:
评价受试制剂和参比制剂单次给药在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacodynamic characteristics of a single injection of the test preparation nadroparin calcium injection and the reference preparation nadroparin calcium injection in healthy adult Chinese subjects and to evaluate the bioequivalence of the two preparations.
Secondary study objectives:
To evaluate the safety of a single administration of the test preparation and the reference preparation in healthy adult Chinese subjects.
/ CompletedNot Applicable 单中心、随机、开放、三周期、三交叉、单剂量口服给药,评估恩曲他滨丙酚替诺福韦片(Ⅱ)在中国健康成人中空腹和餐后状态下生物等效性试验
[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.
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