[Translation] Single center, randomized, open, single oral administration, two preparations, three sequences, three cycles (fasting)/two sequences, four cycles ( After meal) human bioequivalence test
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂富马酸丙酚替诺福韦片(规格:25mg(以C21H29N6O5P计);生产企业:湖南一格制药有限公司)和参比制剂富马酸丙酚替诺福韦片(商品名:VEMLIDY®;规格:25mg(以丙酚替诺福韦计);持证商:Gilead Sciences International Ltd.)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂富马酸丙酚替诺福韦片和参比制剂富马酸丙酚替诺福韦片(VEMLIDY®)在中国健康受试者中的安全性。
[Translation] Main purpose: To observe Chinese healthy subjects taking a single oral administration of the test preparation tenofovir alafenamide tablets (specification: 25mg (calculated as C21H29N6O5P) in the state of fasting/after meal; manufacturer: Hunan Yige Pharmaceutical Co., Ltd. company) and the reference preparation tenofovir alafenamide tablets (trade name: VEMLIDY®; specification: 25mg (calculated as tenofovir alafenamide); licensee: Gilead Sciences International Ltd.) Kinetic characteristics, to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary purpose: To observe the safety of the test preparation tenofovir alafenamide fumarate tablets and the reference preparation tenofovir alafenamide fumarate tablets (VEMLIDY®) in Chinese healthy subjects.