Bioequivalence of 400 mg Moxifloxacin Tablet in Healthy Thai Volunteers

Abstract

Moxifloxacin-HCl, a fluoroquinolone, is a broad spectrum antibacterial agent against
respiratory tract pathogens, including Gram-positive and Gram-negative bacteria, anaerobic
bacteria and atypical respiratory tract pathogens. In order to ensure the efficacy and safety of
generic moxifloxacin formulations, the bioequivalence study of these products need to be
evaluated. Thus the aim of this study was to compare the rate and extent of absorption of a
new generic moxifloxacin formulation (Rapiflox®, Atlantic Laboratories Corporation Ltd.,
Bangkok, Thailand) with that of a Reference formulation (Avelox®, Bayer HealthCare AG,
Leverkusen, Germany) when given at a dose of 400 mg. A single dose randomized two
treatments, crossover with 2 weeks washout period was performed in twenty health Thai
volunteers. The subjects received either 400 mg of the Reference or Test formulation. Blood
samples were collected at predose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 34 hr
post dose. Moxifloxacin plasma level was measured by HPLC with fluorescence detector.
Pharmacokinetic parameters were calculated using non-compartmental model. The mean Cmax
+ SD for the Test and Reference formulations were 4,279.1 + 1,186.5 and 4,302.5 + 976.9
ng/ml, respectively. Furthermore, the mean + SD of AUC0-t for the Test and Reference
formulations were 50,686.4 + 9,148.7 and 52,535.3 + 8,548.9 ng.hr.ml-1 whereas AUC0-∝
were 52,777.5 + 9,016.5 and 55,048.9 + 8,615.7, ng.hr.ml-1, respectively. The mean Tmax for
Test and Reference formulations were 2.01 + 1.57 and 2.24 + 1.87 hr, respectively. The mean
ratios (90% confidence intervals) for pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞
were 0.9963 (0.8321-1.1219), 0.9962 (0.8707-1.0534) and 0.9957 (0.8652-1.0485),
respectively. Therefore, it can be concluded that two moxifloxacin tablets (Test and
Reference formulation) were bioequivalent in healthy Thai volunteers under fasting
condition.