[Translation] A single-center, randomized, open-label, two-preparation, single-dose, single-cycle, parallel-designed bioequivalence trial of Hydroxychloroquine Sulfate Tablets in Chinese healthy subjects under fasting/postprandial conditions.
本试验为生物等效性试验,以Sanofi-Aventis持证的硫酸羟氯喹片(商品名:PLAQUENIL®,规格:0.2g)为参比制剂,以重庆博腾药业有限公司生产的硫酸羟氯喹片(规格:0.2g)为受试制剂,通过单中心、随机、开放、两制剂、单剂量、单周期、平行设计试验,评价两种制剂在空腹及餐后给药条件下的生物等效性。
[Translation] This test is a bioequivalence test, using Sanofi-Aventis’ certified hydroxychloroquine sulfate tablets (trade name: PLAQUENIL®, specification: 0.2g) as the reference preparation, and hydroxychloroquine sulfate produced by Chongqing Boteng Pharmaceutical Co., Ltd. The tablet (specification: 0.2g) is the test preparation. Through a single-center, randomized, open-label, two-preparation, single-dose, single-cycle, parallel design trial, the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated. sex.