一项单中心、随机、开放、单剂量、三周期半重复交叉研究评价沈阳金龙药业有限公司生产的阿奇霉素颗粒(Ⅱ)与希舒美®的生物等效性
[Translation] A single-center, randomized, open-label, single-dose, three-cycle semi-replicated crossover study to evaluate the bioequivalence of azithromycin granules (II) produced by Shenyang Jinlong Pharmaceutical Co., Ltd. and Zithromax®
主要目的:以沈阳金龙药业有限公司生产的阿奇霉素颗粒(Ⅱ)(规格:0.1 g)为受试制剂,以辉瑞制药有限公司生产的阿奇霉素干混悬剂(规格:0.1 g,商品名:希舒美®)为参比制剂,通过单中心、随机、开放、单次给药、三周期半重复交叉临床研究来评价两种制剂空腹及餐后状态下的人体生物等效性。
次要目的: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] Main purpose: Azithromycin granules (II) produced by Shenyang Jinlong Pharmaceutical Co., Ltd. (specification: 0.1 g) were used as the test preparation, and azithromycin dry suspension produced by Pfizer Pharmaceutical Co., Ltd. (specification: 0.1 g, trade name: Xi Shumei®) is the reference preparation. The human bioequivalence of the two preparations in fasting and postprandial states was evaluated through a single-center, randomized, open-label, single-dose, three-cycle and semi-repeated crossover clinical study.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
100 Clinical Results associated with SHENYANG JINLONG PHARMACEUTICAL CO.,LTD
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100 Translational Medicine associated with SHENYANG JINLONG PHARMACEUTICAL CO.,LTD