Parameter Geometric Mean Ratio, % (90% CI) Probability of Exceeding Limits of Acceptance Power P<80% P<125% Full data set         Cmax 98.17 (88.67, 108.70) <0.001 <0.001 0.97 AUC0–t 97.53 (94.32, 100.84) <0.001 <0.001 1.00 AUC0–∞ 92.84 (82.23, 104.81) 0.023 <0.001 0.92 Reduced data set         Cmax 98.17 (88.67, 108.70) <0.001 <0.001 0.97 AUC0–t 99.94 (97.44, 102.50) <0.001 <0.001 1.00 AUC0–∞ 101.19 (97.70, 104.82) <0.001 <0.001 1.00 The full data set includes all of the subjects, including all of their concentration values. The reduced data set includes all of the subjects, with the single exception of the last concentration value (72-hours, reference formulation) for the subject identified as number 12. AUC0–t =AUC from time 0 (baseline) to the last measurable concentration; AUC0–∞= AUC from baseline extrapolated to infinity. *Values were calculated from the natural logarithm-transformed data. † Trademark: ZIinolox 4G® (Laboratorios Liomont, S. A. de C. V., Mexico City, Mexico). ‡Trademark: Avelox® (Bayer de México, S. A. de C. V., Mexico City, Mexico).

Table 2: Geometric mean ratios (90% CI) of pharmacokinetic parameters*, the probabilities of exceeding the predetermined limits of bioequivalence (80%- 125%), and the power test results from a single-dose administration of a test† and a reference‡ formulation of oral moxifloxacin 400 mg in healthy Mexican adult subjects.

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