Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy Chinese volunteers

Antimicrobial Agents and Chemotherapy

Volumn 58, Issue 10, 2014, Pages 6116-6121

  Cao, Guo Ying ^a,b   Zhang, Jing ^a,b   Zhang, Ying Yuan ^a,b   Guo, Bei Ning ^a,b   Yu, Ji Cheng ^a,b   Wu, Xiao Jie ^a,b   Chen, Yuan Cheng ^a,b   Wu, Ju Fang ^a   Shi, Yao Guo ^a,b  

^a FUDAN UNIVERSITY   (China)

^b National Health and Family Planning Commission   (China)

Author keywords

[No Author keywords available]

Indexed keywords

CETIRIZINE; CREATINE KINASE; NEMONOXACIN; PLACEBO; ANTIINFECTIVE AGENT; QUINOLONE DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; CHINESE; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CROSSOVER PROCEDURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERANCE; ECG ABNORMALITY; ELIMINATION HALF-LIFE; ERYTHEMA; FEMALE; FIRST IN HUMAN STUDY; HUMAN; HUMAN EXPERIMENT; INJECTION SITE REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MEAN RESIDENCE TIME; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; URINALYSIS; VOLUME OF DISTRIBUTION; INTRAVENOUS DRUG ADMINISTRATION;

ADMINISTRATION, INTRAVENOUS; ANTI-BACTERIAL AGENTS; DOUBLE-BLIND METHOD; HEALTHY VOLUNTEERS; HUMANS; QUINOLONES;

EID: 84907907796     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.02972-14     Document Type: Article

References (13)

1. Wang F, Zhang Y. 2012. Chapter 12. In Practical anti-infective therapeutics, 2nd ed. Peoples Medical Publishing House, Beijing, China.
2. Roychoudhury S, Twinem T, Makin KM, McIntosh EJ, Ledoussal B, Catrenich CE. 2001. Activity of non-fluorinated quinolones (NFQs) against quinolone-resistant Escherichia coli and Streptococcus pneumoniae. J. Antimicrob. Chemother. 48:29-36.
3. Chen YH, Liu CY, Lu JJ, King CH, Hsueh PR. 2009. In vitro activity of nemonoxacin (TG-873870), a novel non-fluorinated quinolone, against clinical isolates of Staphylococcus aureus, enterococci and Streptococcus pneumoniae with various resistance phenotypes in Taiwan. J. Antimicrob. Chemother. 64:1226-1229. .
4. Adam HJ, Laing NM, King CR, Lulashnyk B, Hoban DJ, Zhanel GG. 2009. In vitro activity of nemonoxacin, a novel nonfluorinated quinolone, against 2,440 clinical isolates. Antimicrob. Agents Chemother. 53:4915-4920. .
5. Andersson MI, MacGowan AP. 2003. Development of the quinolones. J. Antimicrob. Chemother. 51 (Suppl 1):1-11.
6. Arjona A. 2009. Nemonoxacin. Drugs Future 34:196-203. .
7. Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J. 2012. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin. Drug Invest. 32:475-486.
8. Guo B, Zhang J, Yu J, Wu X, Shi Y, Tsai CY. 2012. A liquid chromatography-tandem mass spectrometry assay for the determination of nemonoxacin (TG-873870), a novel nonfluorinated quinolone, in human plasma and urine and its application to a single-dose pharmacokinetic study in healthy Chinese volunteers. Biomed. Chromatogr. 26:1333-1340. .
9. Lin L, Chang LW, Tsai CY, Hsu CH, Chung DT, Aronstein WS, Ajayi F, Kuzmak B, Lyon RA. 2010. Dose escalation study of the safety, tolerability, and pharmacokinetics of nemonoxacin (TG-873870), a novel potent broad-spectrum nonfluorinated quinolone, in healthy volunteers. Antimicrob. Agents Chemother. 54:405-410.
10. Chung DT, Tsai CY, Chen SJ, Chang LW, King CH, Hsu CH, Chiu KM, Tan HC, Chang YT, Hsu MC. 2010. Multiple-dose safety, tolerability, and pharmacokinetics of oral nemonoxacin (TG-873870) in healthy volunteers. Antimicrob. Agents Chemother. 54:411-417.
11. Rodvold KA, Danziger LH, Gotfried MH. 2003. Steady-state plasma and bronchopulmonary concentrations of intravenous levofloxacin and azithromycin in healthy adults. Antimicrob. Agents Chemother. 47: 2450-2457. .
12. Zhao M, Yang JB, Xie SM. 2008. Discussion on basic requirement and concerned questions in human tolerance test of new anti-bacterial drugs. Chin. J. Clin. Pharmacol. 24:373-375. (In Chinese.)
13. Food and Drug Administration. 2005. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Food and Drug Administration, Washington, DC. .