他替瑞林片随机、开放、两制剂、两周期、双交叉在健康人体餐后条件下生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of talatirelin tablets in healthy volunteers under postprandial conditions
主要目的:评价在餐后给药条件下,受试制剂他替瑞林片(四川科伦药业股份有限公司生产)5mg和参比制剂他替瑞林片(商品名:Ceredist®,田辺三菱製薬株式会社生产)5mg在中国健康受试者中的生物等效性。
次要目的:评价中国健康成人受试者餐后口服试验药物他替瑞林片的安全性。
[Translation] Main purpose: To evaluate the test preparation Tatirelin Tablets (manufactured by Sichuan Kelun Pharmaceutical Co., Ltd.) 5 mg and the reference preparation Tatirelin Tablets (trade name: Ceredist®, Mitsubishi Tabei) under postprandial administration conditions. Bioequivalence of 5 mg (manufactured by Seiko Co., Ltd.) in Chinese healthy subjects.
Secondary objective: To evaluate the safety of oral administration of the experimental drug tartirelin tablets to healthy adult subjects in China after meals.
他替瑞林片随机、开放、两制剂、两周期、双交叉在健康人体空腹条件下生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of talatirelin tablets in healthy volunteers under fasting conditions
主要目的:评价在空腹给药条件下,受试制剂他替瑞林片(四川科伦药业股份有限公司生产)5mg和参比制剂他替瑞林片(商品名:Ceredist®,田辺三菱製薬株式会社生产)5mg在中国健康受试者中的生物等效性。
次要目的:评价中国健康成人受试者空腹口服试验药物他替瑞林片的安全性。
[Translation] Main purpose: To evaluate the efficacy of the test preparation Tatirelin Tablets (manufactured by Sichuan Kelun Pharmaceutical Co., Ltd.) 5 mg and the reference preparation Tatirelin Tablets (trade name: Ceredist®, manufactured by Mitsubishi Tabae) under fasting administration conditions. Bioequivalence of 5 mg (produced by 薬有限公司) in Chinese healthy subjects.
Secondary objective: To evaluate the safety of oral administration of the investigational drug tartirelin tablets to healthy Chinese adult subjects on an empty stomach.
100 Clinical Results associated with Chengdu Jianze Pharmaceutical Technology Co., Ltd.
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100 Deals associated with Chengdu Jianze Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Chengdu Jianze Pharmaceutical Technology Co., Ltd.