[Translation] Single-dose, randomized, open-label, two-dose, two-sequence, two-period, double-crossover, fasting and fed states bioequivalence studies of HQ-0124 tablets (200 mg) in Chinese healthy 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 research purpose: using Sanofi/Aventis. 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, The human bioequivalence of the two preparations in the fasting and postprandial state was evaluated by a single-center, randomized, open-label, single-administration, two-period, double-crossover clinical study.
Secondary research purpose: To observe the safety of the test preparation and the control preparation in Chinese healthy subjects.