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- Title
A bioequivalence study of two levofloxacin tablets in healthy male subjects.
- Authors
Inbum Chung; Seonghae Yoon; SoJeong Yi; Bo-Hyung Kim; Sung-Vin Yim; In-Jin Jang; Howard Lee
- 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 (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.
- Subjects
THERAPEUTIC equivalency in drugs; BIOPHARMACEUTICAL research; FLUOROQUINOLONES; ANTIBIOTICS; PHARMACOKINETICS; DRUG dosage
- Publication
Translational & Clinical Pharmacology, 2014, Vol 22, Issue 2, p102
- ISSN
2289-0882
- Publication type
Article
- DOI
10.12793/tcp.2014.22.2.102