[Translation] Single-center, randomized, open-label, single-dose, dual-dose, dual-sequence, four-cycle, fully replicated crossover design of tenofovir fumarate tablets in healthy subjects under fasting and postprandial conditions Human Bioequivalence Test
评价中国健康受试者空腹及餐后条件下口服受试制剂富马酸丙酚替诺福韦片(规格:25mg,海南中和药业股份有限公司)和参比制剂富马酸丙酚替诺福韦片(商品名:Vemlidy,规格:25mg,持证商:Gilead Sciences Inc,生产商:Patheon Inc.)后的药代动力学特点和生物等效性。同时评价富马酸丙酚替诺福韦片在健康受试者中的安全性。
[Translation] Evaluation of oral test preparation tenofovir fumarate tablets (specification: 25 mg, Hainan Zhonghe Pharmaceutical Co., Ltd.) and reference preparation alafenamide fumarate under fasting and postprandial conditions in healthy Chinese subjects Pharmacokinetic characteristics and bioequivalence of Novovir tablets (trade name: Vemlidy, strength: 25mg, licensee: Gilead Sciences Inc, manufacturer: Patheon Inc.). The safety of tenofovir fumarate tablets in healthy subjects was also evaluated.