盐酸安妥沙星注射液治疗社区获得性肺炎的多中心、随机、双盲、阳性药平行对照Ⅱ期临床研究
[Translation] A multicenter, randomized, double-blind, positive-drug parallel-controlled phase II clinical study of antofloxacin hydrochloride injection in the treatment of community-acquired pneumonia
本项试验以盐酸左氧氟沙星注射液为对照药,通过多中心、随机、双盲、平行对照临床试验的方法初步评价盐酸安妥沙星注射液400mg QD给药方案治疗社区获得性肺炎的安全性和有效性,为Ⅲ期临床试验方案设计提供依据。
[Translation] This trial used levofloxacin hydrochloride injection as the control drug, and preliminarily evaluated the safety and efficacy of 400 mg QD dosing regimen of levofloxacin hydrochloride injection in the treatment of community-acquired pneumonia through a multicenter, randomized, double-blind, parallel-controlled clinical trial, providing a basis for the design of the Phase III clinical trial.
盐酸安妥沙星注射液治疗肾盂肾炎的多中心、随机、双盲、阳性药平行对照Ⅱ期临床研究
[Translation] A multicenter, randomized, double-blind, positive-drug parallel-controlled phase II clinical study of antofloxacin hydrochloride injection in the treatment of pyelonephritis
本项试验以盐酸左氧氟沙星注射液为对照药,通过多中心、随机、双盲、平行对照临床试验的方法初步评价盐酸安妥沙星注射液400mg QD给药方案治疗肾盂肾炎的安全性和有效性,为Ⅲ期临床试验方案设计提供依据。
[Translation] This trial used levofloxacin hydrochloride injection as the control drug, and preliminarily evaluated the safety and efficacy of 400 mg QD dosing regimen of levofloxacin hydrochloride injection in the treatment of pyelonephritis through a multicenter, randomized, double-blind, parallel-controlled clinical trial method, providing a basis for the design of the Phase III clinical trial protocol.
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