一项随机、开放、两制剂、两序列交叉设计，评价健康成人空腹或餐后状态下单次口服来特莫韦片的生物等效性研究
[Translation] A randomized, open-label, two-dose, two-sequence crossover design to evaluate the bioequivalence of a single oral dose of letermovir tablets in healthy adults in the fasting or fed state
主要目的：考察健康受试者在空腹/餐后条件下单次口服来特莫韦片（规格：240mg）（江西迪赛诺医药集团有限公司生产）与普瑞明®（规格：240mg）（持证商：Merck Sharp & Dohme B.V.）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：观察单剂量口服来特莫韦片（规格：240mg）受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of Letermovir Tablets (Specification: 240 mg) (produced by Jiangxi Desano Pharmaceutical Group Co., Ltd.) and Premin® (Specification: 240 mg) (licensed by Merck Sharp & Dohme B.V.) in healthy subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation and reference preparation of Letermovir Tablets (Specification: 240 mg) in healthy subjects after a single oral administration.
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 and amlodipine tablets (III) (10 mg/5 mg) in healthy volunteers under fasting or fed 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] Primary objective: To investigate the in vivo pharmacokinetic characteristics of perindopril amlodipine tablets (III) (specification: each tablet contains 10 mg perindopril arginine and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Jiangxi Desano Pharmaceutical Group Co., Ltd. and perindopril amlodipine tablets (III) (Kesoda®, specification: each tablet contains 10 mg perindopril arginine and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Servier (Ireland) Industries Ltd in healthy Chinese subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test and reference preparations of perindopril amlodipine tablets (III) in healthy Chinese subjects after single oral administration.
100 Clinical Results associated with Jiangxi Desaino Pharmaceutical Group Co., Ltd.
0 Patents (Medical) associated with Jiangxi Desaino Pharmaceutical Group Co., Ltd.
100 Deals associated with Jiangxi Desaino Pharmaceutical Group Co., Ltd.
100 Translational Medicine associated with Jiangxi Desaino Pharmaceutical Group Co., Ltd.
