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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date10 Aug 1972 |
注射用D(-)磺苄西林钠健康受试者单次和多次给药耐受性、药动学及与注射用磺苄西林钠比较药动学研究
[Translation] Study on the tolerance and pharmacokinetics of single and multiple doses of D(-) sulbenicillin sodium for injection in healthy subjects and its pharmacokinetics compared with sulbenicillin sodium for injection
1) 评价注射用D(-)磺苄西林钠在健康受试者中单次和多次给药的安全性、耐受性和药代动力学特征,为II期临床试验给药方案提供安全剂量范围,为制定合理的临床方案提供依据。 2)比较注射用D(-)磺苄西林钠和含有相同D(-)磺苄西林钠剂量的注射用磺苄西林钠在健康受试者中单次给药的药代动力学特征和尿药排泄情况。
[Translation] 1) To evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple administrations of D(-) sulbenicillin sodium for injection in healthy subjects, to provide a safe dosage range for the dosing regimen of Phase II clinical trials, and to provide a basis for the formulation of a reasonable clinical regimen. 2) To compare the pharmacokinetic characteristics and urinary drug excretion of single administration of D(-) sulbenicillin sodium for injection and sulbenicillin sodium for injection containing the same dose of D(-) sulbenicillin sodium in healthy subjects.
随机、开放、三周期交叉、单次给药评价左奥硝唑分散片的相对生物利用度和生物等效性研究
[Translation] A randomized, open-label, three-period crossover, single-dose study to evaluate the relative bioavailability and bioequivalence of levornidazole dispersible tablets
本试验旨在研究空腹及餐后单次口服湖南华纳大药厂股份有限公司研制、生产的受试制剂(左奥硝唑分散片、左奥硝唑胶囊)的药代动力学特征,并以湖南华纳大药厂股份有限公司生产的左奥硝唑片作为参比制剂,比较三种制剂的药动学参数,评价两种受试制剂相对于参比制剂的相对生物利用度及人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of the test preparations (levonidazole dispersible tablets and levonidazole capsules) developed and produced by Hunan Warner Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after meals, and to use the levonidazole tablets produced by Hunan Warner Pharmaceutical Co., Ltd. as the reference preparation to compare the pharmacokinetic parameters of the three preparations and evaluate the relative bioavailability and human bioequivalence of the two test preparations relative to the reference preparation.
随机、开放、三周期交叉、单次给药评价左奥硝唑胶囊的相对 生物利用度和生物等效性研究
[Translation] A randomized, open-label, three-period crossover, single-dose study to evaluate the relative bioavailability and bioequivalence of levonidazole capsules
本试验旨在研究空腹及餐后单次口服湖南华纳大药厂股份有限公司研制、生产的受试制剂(左奥硝唑分散片、左奥硝唑胶囊)的药代动力学特征,并以湖南华纳大药厂股份有限公司生产的左奥硝唑片作为参比制剂,比较三种制剂的药动学参数,评价两种受试制剂相对于参比制剂的相对生物利用度及人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of the test preparations (levonidazole dispersible tablets and levonidazole capsules) developed and produced by Hunan Warner Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after meals, and to use the levonidazole tablets produced by Hunan Warner Pharmaceutical Co., Ltd. as the reference preparation to compare the pharmacokinetic parameters of the three preparations and evaluate the relative bioavailability and human bioequivalence of the two test preparations relative to the reference preparation.
100 Clinical Results associated with Changsha Huamei Medical Technology Co., Ltd.
0 Patents (Medical) associated with Changsha Huamei Medical Technology Co., Ltd.
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100 Translational Medicine associated with Changsha Huamei Medical Technology Co., Ltd.