| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Chen, Qian Liu, Yan-mei Liu, Yun Mendzelevski, Boaz Chanter, Dennis Pu, Hua-hua Liu, Gang-yi Weng, Onglee Hu, Chao-ying Wang, Wei Yu, Chen Jia, Jing-ying |
| Description |
Country affiliation: China Author Affiliation: Chen Q ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Liu YM ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Liu Y ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Mendzelevski B ( CoreLab Partners Inc, London, UK.); Chanter D ( CoreLab Partners Inc, London, UK.); Pu HH ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Liu GY ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Weng O ( CoreLab Partners Inc, Shanghai 200031, China.); Hu CY ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Wang W ( Department of Emergency, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Yu C ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.); Jia JY ( Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai 200031, China.) |
| 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. |
| File Format |
HTM / HTML |
| ISSN |
16714083 |
| e-ISSN |
17457254 |
| DOI |
10.1038/aps.2014.153 |
| Journal |
Acta Pharmacologica Sinica |
| Issue Number |
4 |
| Volume Number |
36 |
| Language |
English |
| Publisher |
Macmillan Publishers Limited |
| Publisher Date |
2015-04-01 |
| Publisher Place |
United States |
| Access Restriction |
Open |
| Subject Keyword |
Discipline Pharmacology Fluoroquinolones Administration & Dosage Adverse Effects Heart Rate Drug Effects Long Qt Syndrome Chemically Induced Topoisomerase Ii Inhibitors Administration, Oral Adolescent Asian Continental Ancestry Group Cross-over Studies Dose-response Relationship, Drug Blood Physiopathology Single-blind Method Clinical Trial Randomized Controlled Trial |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Pharmacology Pharmacology (medical) |
