一项评价YK-2001注射液治疗成人社区获得性细菌性肺炎的有效性与安全性随机、双盲、阳性药物平行对照、多中心Ⅲ期临床研究
[Translation] A randomized, double-blind, positive drug parallel-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of YK-2001 injection in the treatment of community-acquired bacterial pneumonia in adults
主要研究目的:
评价YK-2001注射液治疗成人社区获得性细菌性肺炎的有效性。
次要研究目的:
评价YK-2001注射液治疗成人社区获得性细菌性肺炎的安全性。
通过群体PK/PD分析评价影响YK-2001注射液治疗成人社区获得性细菌性肺炎有效性和安全性的内在因素和外在因素。
[Translation] Primary study objectives:
To evaluate the effectiveness of YK-2001 injection in treating community-acquired bacterial pneumonia in adults.
Secondary study objectives:
To evaluate the safety of YK-2001 injection in treating community-acquired bacterial pneumonia in adults.
To evaluate the intrinsic and extrinsic factors affecting the effectiveness and safety of YK-2001 injection in treating community-acquired bacterial pneumonia in adults through population PK/PD analysis.
富马酸西他沙星注射液治疗急性肾盂肾炎/复杂性尿路感染的有效性与安全性随机、盲法、阳性药物平行对照、多中心Ⅱ期临床研究
[Translation] A randomized, blinded, positive drug parallel controlled, multicenter phase II clinical study on the efficacy and safety of sitafloxacin fumarate injection in the treatment of acute pyelonephritis/complicated urinary tract infection
富马酸西他沙星注射液治疗急性肾盂肾炎/复杂性尿路感染的有效性和安全性,并探索最佳有效剂量。
[Translation] To evaluate the efficacy and safety of sitafloxacin fumarate injection in the treatment of acute pyelonephritis/complicated urinary tract infection and to explore the optimal effective dose.
注射用左旋奥拉西坦改善颅脑损伤患者记忆与智能障碍的随机、双盲、阳性药/安慰剂平行对照Ⅲ期临床
[Translation] A randomized, double-blind, active drug/placebo parallel controlled phase III clinical trial of levoxiracetam for injection to improve memory and intellectual impairment in patients with craniocerebral injury
评价注射用左旋奥拉西坦改善颅脑损伤患者记忆与智能障碍的有效性和安全性。
[Translation] To evaluate the efficacy and safety of L-oxiracetam for injection in improving memory and intellectual impairment in patients with craniocerebral injury.
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