Table 2.
Mean derived pharmacokinetic profiles for ibuprofen and paracetamol after administration of the fixed-dose combination tables in the fed and fasted states (Study 1)
Ibuprofen | Paracetamol | |||
---|---|---|---|---|
Fed | Fasted | Fed | Fasted | |
n | 25 | 25 | 25 | 25 |
tmax, hrs | 2.00a | 1.25a | 1.50a | 0.50a |
Median difference [minutes] fed vs fasted, 95% CI | 25.0, 0.0-45.0 | 55.0, 30.0-80.0 | ||
t1/2, hrs | 2.25 | 1.95 | 2.73 | 2.83 |
Cmax, μg.mL-1 | 24.74 | 32.04 | 11.14 | 18.48 |
LS geometric mean | 24.03 | 31.46 | 10.71 | 17.58 |
Ratio fed/fasted (%), 90% CI | 76.38, 70.25-83.06 | 60.92, 53.43-69.46 | ||
AUC0-t, μg.mL-1.hr | 103.91 | 118.32 | 46.45 | 51.69 |
LS geometric mean | 101.6 2 | 116.51 | 45.69 | 50.27 |
Ratio fed/fasted (%), 90% CI | 87.22, 84.06-90.49 | 90.89, 87.38-94.54 | ||
AUC0-inf, μg.mL-1.hr | 109.03 | 120.92 | 49.51 | 54.49 |
LS geometric mean | 106.04 | 118.82 | 48.72 | 52.95 |
Ratio fed/fasted (%), 90% CI | 89.25, 86.14-92.46 | 92.01, 88.45-95.71 | ||
Kel | 0.328 | 0.361 | 0.258 | 0.251 |
AUC0-inf: area under the curve calculated by linear trapezoidal rule to the last measurable plasma concentration (Cp) with additional area calculated from Cp/Kel; AUC0-t: area under the curve calculated by linear trapexoidal rule to the last measurable plasma concentration; Cmax: maximum plasma concentration; Kel: elimination rate constant; tmax: time of maximum plasma concentration; hr(s): hour(s); LS: least square; sd: standard deviation. aMedian values.