[Translation] Study on the bioequivalence of venlafaxine hydrochloride sustained-release capsules in healthy volunteers
试验主要目的:以广东隆信制药有限公司生产的盐酸文拉法辛缓释胶囊为受试制剂,按生物等效性研究的有关规定,与Pfizer Ireland Pharmaceuticals生产的盐酸文拉法辛缓释胶囊(商品名:怡诺思)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。 试验次要目的:观察受试制剂盐酸文拉法辛缓释胶囊和参比制剂(怡诺思)在健康受试者中的安全性。
[Translation] The main purpose of the trial is to use the venlafaxine hydrochloride sustained-release capsules produced by Guangdong Longxin Pharmaceutical Co., Ltd. as the test preparation, and compare the relative bioavailability in healthy humans with the venlafaxine hydrochloride sustained-release capsules (trade name: Effexor) produced by Pfizer Ireland Pharmaceuticals according to the relevant provisions of the bioequivalence study, and investigate the human bioequivalence of the two preparations. The secondary purpose of the trial is to observe the safety of the test preparation venlafaxine hydrochloride sustained-release capsules and the reference preparation (Effexor) in healthy subjects.
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