Orally administered moxifloxacin prolongs QTc in healthy Chinese volunteers: a randomized, single-blind, crossover study.
Acta Pharmacol Sin
; 36(4): 448-53, 2015 Apr.
Article
em En
| MEDLINE
| ID: mdl-25832425
ABSTRACT
AIM:
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.CONCLUSION:
Orally administered moxifloxacin significantly prolongs QTc, which supports its use as a positive control in ICH-E14 TQT studies in Chinese volunteers.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Síndrome do QT Longo
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Fluoroquinolonas
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Inibidores da Topoisomerase II
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Frequência Cardíaca
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article