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本试验旨在研究单次空腹和餐后口服安徽海天信恒药业有限公司研制、华益药业科技(安徽)有限公司生产的盐酸倍他司汀片(8 mg)的药代动力学特征;以Mylan Laboratories SAS生产的盐酸倍他司汀片(Serc®,8 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of betahistine hydrochloride tablets (8 mg) developed by Anhui Haitian Xinheng Pharmaceutical Co., Ltd. and produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.; using betahistine hydrochloride tablets (Serc®, 8 mg) produced by Mylan Laboratories SAS as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Anhui Haitian Xinheng Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Anhui Haitian Xinheng Pharmaceutical Co., Ltd.