[Translation] Mean bioequivalence study of tenofovir disoproxil fumarate tablets in healthy subjects with fasting and meal administration, 2 preparations, 2 cycles, 2 sequences, random crossover
健康受试者在空腹和餐后状态下口服单剂量受试制剂富马酸替诺福韦二吡呋酯片(规格:300mg;海南中玉药业有限公司生产)与单剂量参比制剂富马酸替诺福韦二吡呋酯片(韦瑞德,规格:300mg;Aspen port Elizabeth (Pty) Ltd.公司生产),测定血浆中替诺福韦的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
[Translation] Healthy subjects took a single dose of the test preparation tenofovir disoproxil fumarate tablets (specification: 300 mg; produced by Hainan Zhongyu Pharmaceutical Co., Ltd.) and a single dose of the reference preparation rich in the fasting and postprandial states. Tenofovir disoproxil maleate tablets (Vread, specification: 300mg; produced by Aspen port Elizabeth (Pty) Ltd.), to measure the concentration of tenofovir in plasma, to study the absorption of the test preparation and the reference preparation The speed and degree of absorption are used to evaluate whether the test preparation is bioequivalent to the reference preparation.