/ CompletedNot Applicable 中国健康受试者空腹和餐后单次口服非布司他片的随机、开放、两序列、两周期交叉设计的生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period crossover bioequivalence study of a single oral dose of febuxostat tablets in Chinese healthy volunteers on an empty stomach or after a meal
研究空腹/餐后单次口服非布司他片受试制剂(40 mg/片,江苏华世通生物医药科技有限公司)与非布司他片参比制剂(Feburic®40 mg/片,日本帝人制药株式会社)后非布司他在中国健康受试者体内的药代动力学行为,评价空腹口服两种制剂的生物等效性;评价中国健康受试者单次口服非布司他片受试制剂和参比制剂后的安全性。
[Translation] To study the pharmacokinetic behavior of febuxostat in healthy Chinese subjects after a single oral administration of the test formulation of febuxostat tablets (40 mg/tablet, Jiangsu Huashitong Biopharmaceutical Technology Co., Ltd.) and the reference formulation of febuxostat tablets (Feburic® 40 mg/tablet, Teijin Pharma Ltd., Japan) on an empty stomach/after a meal, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach; and to evaluate the safety of the test and reference formulations of febuxostat tablets in healthy Chinese subjects after a single oral administration.
/ CompletedNot Applicable 单次空腹与餐后用药,两制剂、两周期、两序列、随机、开放、自身交叉的平均生物等效性研究
[Translation] A single fasting and postprandial drug administration, two preparations, two cycles, two sequences, randomized, open, self-crossover average bioequivalence study
本研究以江苏华世通生物医药科技有限公司的苯甲酸阿格列汀片(25mg/片)为受试制剂,原研厂家日本武田药品工业株式会社,大阪工厂生产的苯甲酸阿格列汀片(25mg/片)(商品名:尼欣那®)为参比制剂,评价二者是否为生物等效制剂,为临床安全、合理用药提供理论依据。 次要研究目的: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] This study used alogliptin benzoate tablets (25 mg/tablet) produced by Jiangsu Huashitong Biopharmaceutical Technology Co., Ltd. as the test preparation and alogliptin benzoate tablets (25 mg/tablet) (trade name: Nisina®) produced by the original manufacturer, Takeda Pharmaceutical Co., Ltd., Osaka Plant, as the reference preparation to evaluate whether the two are bioequivalent preparations and provide a theoretical basis for clinical safety and rational drug use. Secondary study objectives: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Jiangsu Huashitong Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Jiangsu Huashitong Biomedical Technology Co., Ltd.
100 Deals associated with Jiangsu Huashitong Biomedical Technology Co., Ltd.
100 Translational Medicine associated with Jiangsu Huashitong Biomedical Technology Co., Ltd.