Transl Clin Pharmacol.  2014 Dec;22(2):102-105. 10.12793/tcp.2014.22.2.102.

A bioequivalence study of two levofloxacin tablets in healthy male subjects

• Chung I
• Yoon S
• Yi S
• Kim BH
• Yim SV
• Jang IJ
• Lee H

• KMID: 2050943
• DOI: http://doi.org/10.12793/tcp.2014.22.2.102

Abstract

Levofloxacin is a bactericidal broad spectrum antibiotic against Gram-positive and Gram-negative pathogens. A randomized, two-treatment, two-period, two-way crossover study was conducted to evaluate the bioequivalence of Lectacin 250 mg tablet, a generic levofloxacin, to its reference drug, Cravit 250 mg tablet. Each period was separated by a 7-day washout. Serial blood samples were collected until 24 h after dosing and plasma levofloxacin concentrations were determined using a high performance liquid chromatography. Pharmacokinetic parameters were analyzed using K-BE Test 2007 and BA calc 2007 (Ministry of Food and Drug Safety, Cheongju-si, South Korea). The peak concentration (Cmax) and the area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC(0-t)) for the generic and reference levofloxacin were 4.48+/-0.89 mg/L and 4.46+/- 0.95 mg/L, and 25.33+/-4.12 mg*h/L and 25.77+/-4.01 mg*h/L, respectively, leading to a geometric mean ratio (90% confidence interval) of the generic to the reference levofloxacin of 1.0060 (0.9339-1.0842) and 0.9810 (0.9476-1.0159), respectively, for Cmax and AUC(0-t). Lectacin 250 mg tablet is bioequivalent to Cravit 250 mg tablet.

Keyword

bioequivalence; levofloxacin; pharmacokinetics

MeSH Terms

Chromatography, Liquid
Chungcheongbuk-do
Cross-Over Studies
Humans
Levofloxacin*
Male
Pharmacokinetics
Plasma
Tablets*
Therapeutic Equivalency*
Tablets

Figure

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  Figure 1. Mean plasma concentration – time curves of levofloxacin after a single oral dose of levofloxacin 250 mg. The error bars represent the standard deviations (Upper: linear scale, Lower: log scale)

Reference

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