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No drug-related serious adverse events occurred. Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes.
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The comprehensive efficacy rate was comparable among the three groups (87.5% for the nemonoxacin 500Â mg group, 93.8% for the nemonoxacin 750Â mg group, and 81.3% for the levofloxacin 500Â mg group). The overall bacteriological success rate was 83.3% in both nemonoxacin groups and 80.0% in the levofloxacin 500Â mg group in the bacteriological FAS.
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At the TOC visit, nemonoxacin at 500Â mg and 750Â mg was proven to be noninferior to levofloxacin at 500Â mg in the FAS in terms of clinical efficacy.
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Clinical and bacteriological responses were determined at the test of cure (TOC) visit in the full analysis set (FAS). One hundred ninety-two patients with CAP were randomized to receive oral nemonoxacin (500 mg or 750 mg) or levofloxacin (500 mg) once daily for 7-10 days. To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. Liu, Yang Zhang, Yingyuan Wu, Jufang Zhu, Demei Sun, Shenghua Zhao, Li Wang, Xuefeng Liu, Hua Ren, Zhenyi Wang, Changzheng Xiu, Qingyu Xiao, Zuke Cao, Zhaolong Cui, Shehuai Yang, Heping Liang, Yongjie Chen, Ping Lv, Yuan Hu, Chengping Lv, Xiaoju Liu, Shuang Kuang, Jiulong Li, Jianguo Wang, Dexi Chang, Liwen Pharmacokinetic/pharmacodynamic integration revealed significantly higher values for Cmax/MIC and AUC/MIC ratios in renal damaged ducks than in healthy ones, indicating the excellent pharmacokinetic characteristics of levofloxacin in renal damaged ducks.Ī randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. Also, the dose of levofloxacin should be reduced in renal damaged ducks. Oral administration of levofloxacin at 10 mg kg−1 bwt may be highly efficacious against susceptible bacteria in ducks. The pharmacokinetic profile of levofloxacin is altered in renal damaged ducks due to the increased serum levofloxacin concentrations compared with that in clinically healthy ducks. The drug was eliminated (t1/2(el at a significant slower rate (3.94 h in renal damaged than in healthy ducks (2.89 h. Following PO administration, the peak serum concentration (Cmax was higher in renal damaged than in healthy ducks and was achieved at maximum time (tmax of 2.47 and 2.05 h, respectively. Total clearance (Cltot in renal damaged ducks (0.20 L kg−1 h−1 was significantly lower as compared to that in healthy ones (0.41 L kg−1 h−1. Following IV administration, elimination half-life (t1/2(β and mean residence time (MRT were longer in renal damaged ducks than in healthy ones. Comparative Pharmacokinetics of Levofloxacin in Healthy and Renal Damaged Muscovy Ducks following Intravenous and Oral Administrationĭirectory of Open Access Journals (Sweden)įull Text Available The pharmacokinetics aspects of levofloxacin were studied in healthy and experimentally renal damaged Muscovy ducks after single intravenous (IV and oral (PO dose of 10 mg kg−1 bwt.