drugset / Trial / NCT01944774
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Phase 2
Completed
207 enrolled
TaiGen Biotechnology Co., Ltd.
QPS-Qualitix · collabR&G Pharma Studies Co.,Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).
Timeline
- Start
- 2013-03
- Primary completion
- 2013-12
- Completion
- 2013-12
Publications
- Wu XJ, Zhang J, Guo BN, Zhang YY, Yu JC, Cao GY, Chen YC, Zhu DM, Ye XY, Wu JF, Shi YG, Chang LW, Chang YT, Tsai CY. Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in healthy Chinese volunteers. Antimicrob Agents Chemother. 2015 Mar;59(3):1446-54. doi: 10.1128/AAC.04039-14. Epub 2014 Dec 22.
- Cao GY, Zhang J, Zhang YY, Guo BN, Yu JC, Wu XJ, Chen YC, Wu JF, Shi YG. Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers. Antimicrob Agents Chemother. 2014 Oct;58(10):6116-21. doi: 10.1128/AAC.02972-14. Epub 2014 Aug 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | Intravenous |
| Subject | Nemonoxacin | Small molecule | 500 mg | Intravenous |
| Subject | Nemonoxacin | Small molecule | 650 mg | Intravenous |