A bioequivalence study of two levofloxacin tablets in healthy male subjects.
10.12793/tcp.2014.22.2.102
- Author:
Inbum CHUNG
1
;
Seonghae YOON
;
Sojeong YI
;
Bo Hyung KIM
;
Sung Vin YIM
;
In Jin JANG
;
Howard LEE
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine, Seoul 110-744, Korea. howardlee@snu.ac.kr
- Publication Type:Original Article
- Keywords:
bioequivalence;
levofloxacin;
pharmacokinetics
- MeSH:
Chromatography, Liquid;
Chungcheongbuk-do;
Cross-Over Studies;
Humans;
Levofloxacin*;
Male;
Pharmacokinetics;
Plasma;
Tablets*;
Therapeutic Equivalency*
- From:Translational and Clinical Pharmacology
2014;22(2):102-105
- CountryRepublic of Korea
- Language:English
-
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.
