/ Active, not recruitingNot Applicable 一项随机、开放、两序列自身交叉设计，评价空腹状态下中国健康受试者单次口服恩格列净片的生物等效性研究
[Translation] A randomized, open-label, two-sequence self-crossover design to evaluate the bioequivalence of a single oral dose of empagliflozin tablets in Chinese healthy subjects in the fasting state
主要目的：考察中国健康受试者在空腹条件下单次口服恩格列净片（规格：25mg）受试制剂（江西迪赛诺医药集团有限公司生产）和参比制剂（商品名JARDIANCE®/欧唐静®，规格：25mg，Boehringer Ingelheim International GmbH持证）后的体内药代动力学特征，评价受试制剂与参比制剂的生物等效性。
次要目的：评价单剂量口服恩格列净片受试制剂（规格：25mg）和参比制剂（商品名： JARDIANCE®/欧唐静®，规格：25mg）在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of the test formulation of empagliflozin tablets (specification: 25 mg) (produced by Jiangxi Desano Pharmaceutical Group Co., Ltd.) and the reference formulation (trade name JARDIANCE®/Otangjing®, specification: 25 mg, licensed by Boehringer Ingelheim International GmbH) in healthy Chinese subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the test formulation and the reference formulation.
Secondary objective: To evaluate the safety of the test formulation of empagliflozin tablets (specification: 25 mg) and the reference formulation (trade name: JARDIANCE®/Otangjing®, specification: 25 mg) in healthy Chinese subjects after a single oral administration.
/ CompletedNot Applicable 一项随机、开放、两序列自身交叉设计，评价空腹或餐后状态下中国健康受试者单次口服乙酰半胱氨酸片的生物等效性研究
[Translation] A randomized, open-label, two-sequence self-crossover design to evaluate the bioequivalence of a single oral dose of acetylcysteine tablets in Chinese healthy subjects in the fasting or fed state
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受试制剂乙酰半胱氨酸片（江西迪赛诺医药集团有限公司生产，规格：600mg）与参比制剂乙酰半胱氨酸片（商品名：Fluimucil®，规格：600mg，Zambon Svizzera SA生产）后的体内药代动力学特征，评价受试制剂与参比制剂的生物等效性。
次要目的：评价单剂量口服受试制剂乙酰半胱氨酸片和参比制剂乙酰半胱氨酸片（商品名：Fluimucil®）在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of the test preparation acetylcysteine tablets (produced by Jiangxi Desano Pharmaceutical Group Co., Ltd., specification: 600 mg) and the reference preparation acetylcysteine tablets (trade name: Fluimucil®, specification: 600 mg, produced by Zambon Svizzera SA) after a single oral dose in Chinese healthy subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective: To evaluate the safety of a single oral dose of the test preparation acetylcysteine tablets and the reference preparation acetylcysteine tablets (trade name: Fluimucil®) in Chinese healthy subjects.
/ CompletedNot Applicable 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.
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.
