Table 2.

Pharmacokinetics of DFN-15 oral solution and celecoxib 400-mg oral capsules

Parameters	DFN-15 120 mg (n  =  15)	DFN-15 180 mg (n  = 15)	DFN-15 240 mg (n  =  16)	Oral capsules 400 mg (n  =  15)
C max (ng/ml)	1061.9 ± 237.6	1544.9 ± 289.9	1932.5 ± 305.7	611.4 ± 222.2
T max (h)	0.7 (0.5–1.7)	0.7 (0.5–1.0)	1.0 (0.5–2.0)	2.5 (1.7–5.0)
T lag (h)	0.1 (0.0–0.1)	0.1 (0.0–0.1)	0.1 (0.0–0.1)	0.2 (0.1–0.3)
AUC0–15min (ng·h/mL)a	19.2 ± 10.7	26.6 ± 11.8	35.2 ± 17.8	0.3 ± 0.3
AUC0–30min (ng·h/mL)a	149.1 ± 51.0	228.0 ± 68.6	283.2 ± 80.9	9.5 ± 5.8
AUC0–1h (ng·h/mL)b	604.8 ± 165.8	929.5 ± 193.5	1151.8 ± 214.1	103.2 ± 61.8
AUC0–2h (ng·h/mL)	1322.7 ± 248.6	1976.9 ± 382.5	2621.2 ± 378.9	512.5 ± 292.1
${\text{AUC}}_{0-\text{Re f}{T}_{\text{max}}}$ (ng·h/mL)	1569.1 ± 298.5	2334.2 ± 462.3	3156.5 ± 447.9	777.4 ± 401.7
AUC0–T (ng·h/mL)	3059.7 ± 985.2	4633.1 ± 1478.2	6621.6 ± 1840.0	7288.0 ± 2505.8
AUC0–∞ (ng·h/mL)c	3476.9 ± 1176.8	5234.8 ± 1423.7	6827.7 ± 1857.5	8074.9 ± 2159.3
AUC0–T/∞ (%)c	93.6 ± 4.7	95.5 ± 3.3	96.9 ± 2.2	91.7 ± 7.6
t ½ (h)c	4.5 ± 1.6	4.4 ± 1.5	4.7 ± 1.6	9.8 ± 3.1
Mean relative bioavailability (%)	144	144	141	100

AUC area under the plasma concentration–time curve, $AU{C}_{0-f\text{Re}f{T}_{\text{max}}}$ AUC from baseline through T _max, AUC _0–T AUC from baseline through the last measured concentration, AUC _0–15min AUC from baseline through 15 min post-dose, AUC _0–30min AUC from baseline through 30 min post-dose, AUC _0–1h AUC from baseline through 1 h post-dose, AUC _0–2h AUC from baseline through 2 h post-dose, AUC _0–∞ AUC extrapolated to infinity, AUC _0–T/∞ AUC_0–T with respect to AUC_0–∞, C _max maximum observed plasma concentration, T _lag time before the first measurable concentration, T _max time to peak concentration, t _½ terminal half-life, λ _Z apparent elimination rate constant

^a n  =  11 for DFN-15 120 mg, n  =  13 for DFN-15 180 mg, n  =  14 for DFN-15 240 mg, and n  =  13 for celecoxib 400 mg

^b n  =  12 for DFN-15 120 mg, n  =  14 for DFN-15 180 mg, n  =  14 for DFN-15 240 mg, and n  =  14 for celecoxib 400 mg

^c n  =  11 for λ _Z, AUC_0–∞, AUC_0–T/∞, and t _½