[Translation] A single-center, randomized, open-label, single-dose, two-drug, two-sequence, four-period, completely repeated crossover, fasting bioequivalence study of paroxetine hydrochloride enteric-coated sustained-release tablets (25 mg) produced by Baolong Pharmaceutical Co., Ltd. and paroxetine hydrochloride enteric-coated sustained-release tablets (trade name: SEROXAT®, 25 mg) certified by GLAXOSMITHKLINE INC. in healthy subjects
主要研究目的:以GLAXOSMITHKLINE INC.持证的盐酸帕罗西汀肠溶缓释片(商品名:SEROXAT®,25 mg)为参比制剂,以宝龙药业有限公司生产的盐酸帕罗西汀肠溶缓释片(25 mg)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉的临床研究来评价两种制剂在空腹状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比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 the paroxetine hydrochloride enteric-coated sustained-release tablets (trade name: SEROXAT®, 25 mg) certified by GLAXOSMITHKLINE INC. as the reference preparation and the paroxetine hydrochloride enteric-coated sustained-release tablets (25 mg) produced by Baolong Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting state through a single-center, randomized, open, single-dose, two-preparation, two-sequence, four-cycle, completely repeated crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.