| Autor: |
Oliveira, C. F., Dias, H. B., Ribeiro, W., Poli, A., Peixoto, A. P., Moraes, M. E. A., Moraes, M. O., Bezerra, F. A. F., Moreno, H., Muscará, M. N., de Nucci, G. |
| Zdroj: |
Clinical Research and Regulatory Affairs; 1999, Vol. 16 Issue: 1-2 p29-40, 12p |
| Abstrakt: |
The bioavailability of two ofloxacin (OFX) tablet formulations (OTT, test formulation from Laboratorio Atral SA - Portugal, and Tarivid, reference formulation from Hoechst AG - Germany) were compared in 24 (12M, 12F) healthy volunteers who received a single oral dose of 200 mg of each formulation in an open, randomized, two-period crossover fashion with a 14 day washout interval between doses. Plasma samples were obtained over a 24 h interval and OFX concentrations were determined by HPLC with UV detection. From the OFX plasma concentration vs time curves, the AUC[0-24] (area under the concentration vs time curves from 0 to 24 h), AUC[0-α] (area under the concentration vs time curves extrapolated to infinity), Cmax (maximum concentration achieved), tmax (time to achieve Cmax), t1/2 (terminal first order elimination half-life), and elimination constant (Ke) were obtained. All these variables were analyzed using both parametric and non-parametric statistics. The two OFX tablet brands did not show statistically significant differences in bioavailability as assessed by the statistical analysis of AUC[0-24] (14.8 and 14.7μg h ml-1, respectively for OTT and Tarivid), AUC[0-α] (16.0 and 15.6 μg h ml-1), Cmax (2.9 and 3.1 μg/ml), tmax (0.8 and 1.5 h), t1/2 (5.9 and 5.6 h), and Ke (0.12 and 0.13 h-1) values. Based on these results and on the United States Food and Drug Administration (FDA) requirements [1993], both formulations were considered to be bioequivalent. |
| Databáze: |
Supplemental Index |
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