[Translation] A single-dose, randomized, open-label, two-dose, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of HQ-0124 tablets (200 mg) in healthy Chinese subjects
主要研究目的:以Sanofi/Aventis.持证的氨磺必利片(200 mg)为对照制剂,以则正(上海)生物科技有限公司研发的HQ-0124片(200 mg)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和对照制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use Sanofi/Aventis.'s licensed amisulpride tablets (200 mg) as the control preparation and HQ-0124 tablets (200 mg) developed by Zezheng (Shanghai) Biotechnology Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the control preparation in healthy Chinese subjects.