title: Orally administered moxifloxacin prolongs QTc in healthy Chinese volunteers: a randomized, single-blind, crossover study.
abstract: OBJECTIVE
  To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers.
  
  
  METHODS
  This was a single-blinded, randomized, single-dose, placebo-controlled, two-period cross-over study. A total of 24 healthy Chinese volunteers were enrolled, randomly assigned to two groups: one group received moxifloxacin (400 mg, po) followed by placebo with a 7-d interval, another group received placebo followed by moxifloxacin with a 7-d interval. On the days of dosing, 12-lead 24 h Holter ECGs were recorded and evaluated by an ECG laboratory blind to the treatments. Blood samples were collected to determine plasma concentrations of moxifloxacin.
  
  
  RESULTS
  The orally administered moxifloxacin significantly prolonged the mean QTc at all time points except 0.5 h post-dose. The largest time-matched difference in the QTcI was 8.35 ms (90% CI: 5.43, 11.27) at 4 h post-dose. The peak effect on QTcF was 9.35 ms (90% CI: 6.36, 12.34) at 3 h post-dose. A pharmacokinetic-QTc model suggested a 2.084 ms increase in the QTc interval for every 1000 ng/mL increase in plasma concentration of moxifloxacin. In addition, the orally administered moxifloxacin was well tolerated by the subjects.
  
  
  CONCLUSIONS
  Orally administered moxifloxacin significantly prolongs QTc, which supports its use as a positive control in ICH-E14 TQT studies in Chinese volunteers.
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Chen
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Yan-mei
authors.initials: YM
authors.lastname: Liu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Liu
authors.affiliation: CoreLab Partners Inc, London, UK.
authors.forename: Boaz
authors.initials: B
authors.lastname: Mendzelevski
authors.affiliation: CoreLab Partners Inc, London, UK.
authors.forename: Dennis
authors.initials: D
authors.lastname: Chanter
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Hua-hua
authors.initials: HH
authors.lastname: Pu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Gang-yi
authors.initials: GY
authors.lastname: Liu
authors.affiliation: CoreLab Partners Inc, Shanghai 200031, China.
authors.forename: Onglee
authors.initials: O
authors.lastname: Weng
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Chao-ying
authors.initials: CY
authors.lastname: Hu
authors.affiliation: Department of Emergency, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Yu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.
authors.forename: Jing-ying
authors.initials: JY
authors.lastname: Jia
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D044466:Asian People; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D016037:Single-Blind Method; D059005:Topoisomerase II Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D055815:Young Adult
chemical_list: D024841:Fluoroquinolones; D059005:Topoisomerase II Inhibitors; D000077266:Moxifloxacin
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