The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol

Table 1 Mean derived pharmacokinetic profiles of ibuprofen and paracetamol after administration of the fixed-dose combination tablet compared with monotherapy (Study 1)

	Ibuprofen (combination)	Ibuprofen (monotherapy)	Paracetamol (combination)	Paracetamol (monotherapy)
n	25	25	25	25
t _max , hrs (median difference [minutes], 95% CI)	1.25^a (7.5, -15.0-37.5)	1.25^a	0.50^a (-15.0, -30.0-0.0)	0.67^a
t _1/2 , hrs	1.95	1.97	2.83	2.66
C _max , μg.mL ^-1	32.04	30.89	18.48	17.49
LS geometric means (ratio test/reference [%], 90% CI)	31.46 (104.29, 95.90-113.41)	30.16	17.58 (104.14, 91.32-118.76)	16.88
AUC _0-t , μg.mL ^-1 .hr	118.32	111.59	51.69	49.47
LS geometric means (ratio test/reference [%], 90% CI)	116.51 (107.08, 103.20-111.11)	108.80	50.27 (104.10, 100.08-108.29)	48.29
AUC _0-inf , μg.mL ^-1 .hr	120.92	114.09	54.49	51.85
LS geometric means (ratio test/reference [%], 90% CI)	118.82 (106.99, 103.26-110.85)	111.06	52.95 (104.6, 100.56-108.82)	50.62

AUC_0-t: area under the curve calculated by linear trapezoidal rule to the last measurable plasma concentration; AUC_0-inf: area under the curve calculated by linear trapezoidal rule to the last measurable plasma concentration (C_p) with additional area calculated from C_p/Kel (elimination rate constant); C_max: maximum plasma concentration; hr(s): hour(s); LS: least square; t_max: the time to occurrence of the maximum plasma concentration; t_1/2: plasma concentration half life. ^aMedian values.