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Int J Clin Pharmacol Ther. 2009 Apr;47(4):283-6.

Comparative bioavailability of two oral formulations of levofloxacin in healthy Mexican volunteers.

Author information

1
Pharmacological Research Unit, National Institute for Respiratory Diseases Ismael Cosío Villegas, Mexico.

Abstract

OBJECTIVE:

To assess the bioequivalence of two levofloxacin 500 mg tablets marketed in Mexico.

MATERIAL AND METHODS:

The clinical investigation was designed as a randomized, open-labeled, two-part, two-treatment, two-period crossover study, in 27 healthy male volunteers. 1 tablet of each formulation was administered with 200 ml of water after 10 h overnight fast. After dosing, serial blood samples were collected for a period of 24 h. Plasma concentrations were determined by a validated high-performance liquid chromatographic method and pharmacokinetic parameters were obtained by non-compartmental approach. Analysis of variance (ANOVA) was carried out using log-transformed AUClast, AUC yen and Cmax and untransformed tmax, and 90% confidence intervals for AUClast, AUC yen and Cmax were calculated. If the 90% confidence intervals (CI) for AUClast, AUC yen and Cmax fell fully within the interval 80 - 125%, the bioequivalence of the two formulations was established.

RESULTS:

The means (test and reference) for AUClast were 58.869 and 56.297 microg x h/ml, for AUC yen were 63.456 and 60.748 microg x h/ml and for Cmax were 8.691 and 8.445 microg/ml. The geometric mean ratios of the test formulation to reference formulation for AUClast, AUC yen and Cmax (CI) were 104.53% (102.73 - 106.36%), 104.37% (102.04 - 106.75%) and 103.45% (95.57 - 111.97%), respectively. All 90% CI for AUClast, AUC yen and Cmax fell within the Mexican Federal Commission for Prevention of Sanitary Risks (COFEPRIS) accepted bioequivalence range of 80 - 125%.

CONCLUSIONS:

Based on the results, the formulations tested are bioequivalent.

PMID:
19356395
DOI:
10.5414/cpp47283
[Indexed for MEDLINE]

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