[Translation] An open-label, randomized, oral, single-dose, two-dose, two-sequence, two-period, crossover bioequivalence trial of venlafaxine hydrochloride sustained-release tablets in healthy Chinese subjects under postprandial conditions
以合肥华方医药科技有限公司研制的盐酸文拉法辛缓释片(75mg)为受试制剂,以Osmotica Pharmaceutical Corp持有VERTICAL PHARMACEUTICALS经销的盐酸文拉法辛缓释片(75mg)做参比制剂,按人体生物等效性试验的有关规定及要求,在餐后条件下进行人体药代动力学研究,评估受试制剂与参比制剂在中国健康受试者的生物等效性。评估盐酸文拉法辛缓释片在中国健康受试者中的安全性。
[Translation] Taking Venlafaxine Hydrochloride Sustained-Release Tablets (75mg) developed by Hefei Huafang Pharmaceutical Technology Co., Ltd. as the test preparation, and taking Venlafaxine Hydrochloride Sustained-Release Tablets (75mg) distributed by VERTICAL PHARMACEUTICALS held by Osmotica Pharmaceutical Corp as a reference According to the relevant regulations and requirements of the human bioequivalence test, the human pharmacokinetic study was conducted under postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy Chinese subjects. To evaluate the safety of venlafaxine hydrochloride extended-release tablets in healthy Chinese subjects.