Delving into the Latest Updates on Tibet Duo Rui Pharmaceutical Co., Ltd. with Synapse

Overview

主要目的：以药代动力学参数作为主要终点评价指标，比较在餐后状态下口服受试制剂盐酸文拉法辛缓释胶囊（生产厂家：湖北多瑞药业有限公司）与参比制剂盐酸文拉法辛缓释胶囊（持证商：Pfizer Healthcare Ireland，商品名：EFFEXOR® XR）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。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盐酸文拉法辛缓释胶囊（商品名：EFFEXOR® XR）在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation venlafaxine hydrochloride sustained-release capsules (manufacturer: Hubei Duorui Pharmaceutical Co., Ltd.) and the reference preparation venlafaxine hydrochloride sustained-release capsules (licensed by: Pfizer Healthcare Ireland, trade name: EFFEXOR® XR) in healthy subjects after oral administration in the fed state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation venlafaxine hydrochloride sustained-release capsules and the reference preparation venlafaxine hydrochloride sustained-release capsules (trade name: EFFEXOR® XR) in healthy subjects.

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