甲苯磺酸艾多沙班片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, fully repeated crossover bioequivalence study of edoxaban tosylate tablets in healthy volunteers after single oral administration on an empty stomach or after a meal
主要目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后状态下单剂量口服江西迪赛诺医药集团有限公司持有的甲苯磺酸艾多沙班片(规格:60mg/片)与Daiichi Sankyo Europe GmbH生产的甲苯磺酸艾多沙班片(规格:60mg/片;商品名:里先安®)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:研究单剂量口服甲苯磺酸艾多沙班片(规格:60mg/片)在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of a single oral dose of edoxaban tosylate tablets (60 mg/tablet) produced by Jiangxi Desano Pharmaceutical Group Co., Ltd. and edoxaban tosylate tablets (60 mg/tablet; trade name: Lixianan®) produced by Daiichi Sankyo Europe GmbH in healthy Chinese subjects in the fasting/postprandial state through a fasting/postprandial trial study, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To investigate the safety of a single oral dose of edoxaban tosylate tablets (60 mg/tablet) in healthy Chinese subjects.
健康受试者空腹或餐后状态下单次口服培哚普利氨氯地平片(III)(10mg/5mg)的生物等效性研究
[Translation] Bioequivalence study of single oral administration of perindopril amlodipine tablets (III) (10 mg/5 mg) in healthy subjects under fasting or postprandial conditions
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服江西迪赛诺医药集团有限公司生产的培哚普利氨氯地平片(III)(规格:每片含精氨酸培哚普利10mg和苯磺酸氨氯地平5mg(以氨氯地平计))与Servier(Ireland)IndustriesLtd生产的培哚普利氨氯地平片(III)(开素达®,规格:每片含精氨酸培哚普利10mg和苯磺酸氨氯地平5mg(以氨氯地平计))后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:观察单剂量口服培哚普利氨氯地平片(III)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: To investigate the effect of oral administration of a single dose of Perindopril Amlodipine Tablets (III) produced by Jiangxi Desano Pharmaceutical Group Co., Ltd. to Chinese healthy subjects under fasting/postprandial conditions (specifications: each tablet contains arginine Indopril 10mg and amlodipine besylate 5mg (calculated as amlodipine)) and perindopril amlodipine tablets (III) produced by Servier (Ireland) Industries Ltd (Kaisuda®, specifications: each tablet contains In vivo pharmacokinetic characteristics of perindopril arginine 10 mg and amlodipine besylate 5 mg (calculated as amlodipine) to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of a single dose of oral perindopril amlodipine tablets (III) test preparation and reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Jiangxi Desaino Pharmaceutical Group Co., Ltd.
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