[Translation] Study on the bioequivalence of dexamethasone acetate tablets in healthy volunteers
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定上海世康特制药有限公司生产的醋酸地塞米松片给药后地塞米松在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以SANOFI AVENTIS FRANCE生产的醋酸地塞米松片(商品名:DECTANCYL®)为参比,评价制剂间的生物等效性,并观察在中国健康受试者中的安全性。
[Translation] Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of dexamethasone plasma concentration in healthy subjects after administration of dexamethasone acetate tablets produced by Shanghai Shikangte Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Dexamethasone acetate tablets (trade name: DECTANCYL®) produced by SANOFI AVENTIS FRANCE were used as a reference to evaluate the bioequivalence between the preparations and observe the safety in healthy Chinese subjects.
法莫替丁片(20mg)(受试制剂)与Astellas Pharma的高舒达(法莫替丁片,20mg)(参比制剂)餐后条件下的生物等效性试验。
[Translation] Bioequivalence study of famotidine tablets (20 mg) (test formulation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference formulation) under fed conditions.
主要目的:通过比较餐后条件健康成年人受试者单剂量口服上海世康特制药有限公司生产的法莫替丁片(20mg)(受试制剂)与Astellas Pharma的高舒达(法莫替丁片,20mg)(参比制剂)的吸收速度与吸收程度,来评价两者生物等效性。次要目的:通过临床生物化学、体检和不良事件/严重不良事件监测,来监测参与研究的受试者用药安全性。
[Translation] The primary objective is to evaluate the bioequivalence of famotidine tablets (20 mg) produced by Shanghai Shikangte Pharmaceutical Co., Ltd. (test preparation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference preparation) after a single oral dose in healthy adult subjects under fed conditions. The secondary objective is to monitor the drug safety of the subjects participating in the study through clinical biochemistry, physical examination and adverse event/serious adverse event monitoring.
法莫替丁片(20mg)(受试制剂)与Astellas Pharma的高舒达(法莫替丁片,20mg)(参比制剂)空腹条件下的生物等效性试验。
[Translation] Bioequivalence study of famotidine tablets (20 mg) (test product) and Astellas Pharma's Famotidine Tablets (20 mg) (reference product) under fasting conditions.
主要目的:通过比较空腹条件健康成年人受试者单剂量口服上海世康特制药有限公司生产的法莫替丁片(20mg)(受试制剂)与Astellas Pharma的高舒达(法莫替丁片,20mg)(参比制剂)的吸收速度与吸收程度,来评价两者生物等效性。次要目的:通过临床生物化学、体检和不良事件/严重不良事件监测,来监测参与研究的受试者用药安全性。
[Translation] The primary objective is to evaluate the bioequivalence of famotidine tablets (20 mg) produced by Shanghai Shikangte Pharmaceutical Co., Ltd. (test preparation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference preparation) after a single oral dose in healthy adult subjects under fasting conditions. The secondary objective is to monitor the drug safety of the subjects participating in the study through clinical biochemistry, physical examination and adverse event/serious adverse event monitoring.
100 Clinical Results associated with Shanghai Shikangte Pharmaceutical Co.,Ltd.
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