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KMID : 1038020140220020102
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Translational and Clinical Pharmacology
2014 Volume.22 No. 2 p.102 ~ p.105
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A bioequivalence study of two levofloxacin tablets in healthy male subjects
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Chung In-Bum
Yoon Seong-Hae
Yi So-Jeong
Kim Bo-Hyung
Yim Sung-Vin
Jang In-Jin
Lee Howard
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Abstract
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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 (AUC0-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 AUC0-t. Lectacin 250 mg tablet is bioequivalent to Cravit 250 mg tablet.
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KEYWORD
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bioequivalence, levofloxacin, pharmacokinetics
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