复方罗红霉素片治疗轻中度急性下呼吸道细菌感染伴有痰液粘稠的随机双盲双模拟阳性药平行对照多中心临床试验
[Translation] A randomized, double-blind, double-dummy, positive-drug parallel controlled multicenter clinical trial of compound roxithromycin tablets in the treatment of mild to moderate acute lower respiratory tract bacterial infections with viscous sputum
以罗红霉素为对照,进一步评价复方罗红霉素片治疗轻、中度急性下呼吸道细菌感染伴有痰液粘稠的安全性和有效性
[Translation] To further evaluate the safety and efficacy of compound roxithromycin tablets in the treatment of mild and moderate acute lower respiratory tract bacterial infections with viscous sputum using roxithromycin as a control
多中心、随机、阳性药平行对照评价复方罗红霉素分散片治疗下呼吸道感染痰液粘稠的有效性和安全性临床研究
[Translation] A multicenter, randomized, positive drug parallel control clinical study to evaluate the effectiveness and safety of compound roxithromycin dispersible tablets in the treatment of lower respiratory tract infection with sputum viscosity
评价复方罗红霉素分散片治疗下呼吸道感染伴痰液粘稠的有效性与安全性
[Translation] To evaluate the efficacy and safety of compound roxithromycin dispersible tablets in the treatment of lower respiratory tract infection with thick sputum
[Translation] Pharmacokinetics of Compound Roxithromycin Dispersible Tablets in Human Body
考察受试制剂中两种主药(罗红霉素与盐酸氨溴索)的体内吸收程度和吸收速度是否与单方有显著性差异,并考察罗红霉素与盐酸氨溴索联合使用是否有药物相互作用。考察复方罗红霉素分散片多次给药后的稳态平均血药浓度(Cav),达到稳态时药物谷、峰浓度,及稳态血药浓度的波动系数(DF),多次给药是否存在药物蓄积作用。
[Translation] Examine whether the degree and rate of absorption in the body of the two main drugs in the test preparation (roxithromycin and ambroxol hydrochloride) are significantly different from those of the two main drugs alone, and examine whether the combined use of roxithromycin and ambroxol hydrochloride There are drug interactions. Examine the steady-state average plasma concentration (Cav) of compound roxithromycin dispersible tablets after multiple administrations, the drug trough and peak concentrations when reaching steady state, and the fluctuation coefficient (DF) of steady-state plasma concentration. After multiple administrations, Whether the drug has drug accumulation effect.
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