[Translation] A single-center, randomized, open-label, single-cycle parallel design, single-dose, fasting and postprandial bioequivalence study of hydroxychloroquine sulfate tablets in healthy populations.
主要目的:采用单中心、随机、开放、单次给药、单周期平行试验设计,比较空腹和餐后给药条件下,硫酸羟氯喹片受试制剂与参比制剂在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:评价硫酸羟氯喹片受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Main purpose: Using a single-center, randomized, open-label, single-dose, single-cycle parallel trial design, to compare the absorption of hydroxychloroquine sulfate tablet test preparation and reference preparation in healthy Chinese population under fasting and postprandial conditions and the difference in absorption rate to evaluate bioequivalence.
Secondary objective: To evaluate the safety of test preparations and reference preparations of hydroxychloroquine sulfate tablets in healthy subjects.