[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence trial of dolutegravir/lamivudine/tenofovir tablets (50 mg/300 mg/300 mg) in healthy trial participants under fasting conditions.
主要目的:
在健康男性与女性试验参与者中于空腹条件下,评价受试制剂多替拉韦拉米夫定替诺福韦片(规格:50 mg/300 mg/300 mg,生产商:石家庄龙泽制药股份有限公司)和 ViiV Healthcare 为持证商的参比制剂多替拉韦钠片(Tivicay®,规格:50 mg)、ViiV Healthcare为持证商的参比制剂拉米夫定片(Epivir®,规格:300 mg)、Gilead Sciences, Inc 为持证商的参比制剂富马酸替诺福韦二吡呋酯片(Viread®,规格:300 mg)的生物等效性。
次要目的:
观察受试制剂多替拉韦拉米夫定替诺福韦片与参比制剂多替拉韦钠片(Tivicay®)、拉米夫定片(Epivir®)、富马酸替诺福韦二吡呋酯片(Viread®)在健康试验参与者中的安全性。
[Translation] Primary Objective: To evaluate the bioequivalence of the investigational formulation drolimivir/lamivudine/tenofovir tablets (50 mg/300 mg/300 mg, manufactured by Shijiazhuang Longze Pharmaceutical Co., Ltd.) and the reference formulations drolimivir sodium tablets (Tivicay®, 50 mg), lamivudine tablets (Epivir®, 300 mg), and tenofovir disoproxil fumarate tablets (Viread®, 300 mg), all manufactured by ViiV Healthcare and licensed by Gilead Sciences, Inc., under fasting conditions in healthy male and female participants.
Secondary Objective: To observe the safety of the investigational formulation drolimivir/lamivudine/tenofovir tablets compared to the reference formulations drolimivir sodium tablets (Tivicay®), lamivudine tablets (Epivir®), and tenofovir disoproxil fumarate tablets (Viread®) in healthy participants.