/ Not yet recruitingNot Applicable [Translation] A randomized, crossover, single-center bioequivalence study of lamivudine tablets in humans
评价48例健康受试者单剂量(24例)和餐后(24例)口服拉米夫定片受试制剂与参比制剂后的相对生物利用度及人体生物等效性,同时观察拉米夫定片在健康人群中的耐受性和安全性,为该药的申报及临床设计提供参考从依据。
[Translation] To evaluate the relative bioavailability and bioequivalence of the test and reference preparations of lamivudine tablets after single-dose (24 subjects) and post-meal (24 subjects) oral administration in 48 healthy subjects, and to observe the tolerability and safety of lamivudine tablets in healthy subjects, so as to provide a reference for the application and clinical design of the drug.
/ Not yet recruitingNot Applicable 雷美替胺片在健康受试者中随机、开放、两制剂、两序列、四周期重复交叉空腹/餐后 生物等效性试验
[Translation] A randomized, open-label, two-dose, two-sequence, four-cycle repeated crossover fasting/fed bioequivalence study of ramelteon tablets in healthy subjects
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂武汉长联来福制药股份有限公司提供的雷美替胺片与参比制剂雷美替胺片(生产厂家:日本武田药品工业株式会社,商品名:Rozerem®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] Pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behaviors of the test preparation, ramelteon tablets provided by Wuhan Changlian Laifu Pharmaceutical Co., Ltd., and the reference preparation, ramelteon tablets (manufacturer: Takeda Pharmaceutical Company Limited, Japan, trade name: Rozerem®), in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.
/ Not yet recruitingNot Applicable 孟鲁司特钠咀嚼片在健康受试者中随机开放两制剂单次给药两周期双交叉空腹/餐后生物等效性试验研究方案
[Translation] Study plan for a two-period double-crossover fasting/fed bioequivalence study of montelukast sodium chewable tablets in healthy subjects with a single dose of two formulations in a randomized, open-label, double-crossover fashion
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂武汉长联来福制药股份有限公司提供的孟鲁司特钠咀嚼片与参比制剂孟鲁司特钠咀嚼片(生产厂家:Merck Sharp & Dohme Ltd.,商品名:顺尔宁®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] Pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behaviors of the test preparation, montelukast sodium chewable tablets provided by Wuhan Changlian Laifu Pharmaceutical Co., Ltd., and the reference preparation, montelukast sodium chewable tablets (manufacturer: Merck Sharp & Dohme Ltd., trade name: Singulair®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.
100 Clinical Results associated with Wuhan Changlian Laifu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Wuhan Changlian Laifu Pharmaceutical Co., Ltd.
100 Deals associated with Wuhan Changlian Laifu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Wuhan Changlian Laifu Pharmaceutical Co., Ltd.