Delving into the Latest Updates on Guangzhou Renheng 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，分别比较在空腹/餐后状态下口服受试制剂盐酸米诺环素胶囊（持证商：广州仁恒制药有限公司）与参比制剂盐酸米诺环素胶囊（持证商：Pfizer Japan Inc.，商品名：MINOMYCIN®）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：观察受试制剂盐酸米诺环素胶囊和参比制剂盐酸米诺环素胶囊在健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation minocycline hydrochloride capsules (licensed by Guangzhou Yanheng Pharmaceutical Co., Ltd.) and the reference preparation minocycline hydrochloride capsules (licensed by Pfizer Japan Inc., trade name: MINOMYCIN®) in healthy subjects after oral administration in the fasting/postprandial state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation minocycline hydrochloride capsules and the reference preparation minocycline hydrochloride capsules in healthy subjects.

Start Date27 Nov 2023

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Guangzhou Renheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guangzhou Renheng Pharmaceutical Co., Ltd.

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100 Deals associated with Guangzhou Renheng Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Guangzhou Renheng Pharmaceutical Co., Ltd.

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