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. 2017 Jul 26;37(10):937–946. doi: 10.1007/s40261-017-0548-6

Table 3.

Statistical comparison of DFN-15 oral solution and celecoxib 400-mg oral capsules

Parameter Geometric LSMsa Comparison (mg) Ratio (%) 90% CIs Intrasubject CV (%)
DFN-15
120 mg
(n  =  15)b
DFN-15
180 mg
(n  =  15)b
DFN-15
240 mg
(n  =  15)b
Oral capsules
400 mg
(n  =  15)b
C max 1041.4 1512.5 1899.0 565.9 120 vs. 400 184.0 159.4–212.4 23.6
180 vs. 400 267.3 231.5–308.5
240 vs. 400 335.6 290.7–387.4
AUC0–2h c 1291.4 1920.1 2558.5 433.2 120 vs. 400 298.1 245.7–361.7 32.1
180 vs. 400 443.2 365.3–537.8
240 vs. 400 590.6 486.8–716.6
AUC0-Re fTmax 1530.4 2264.3 3071.6 680.2 120 vs. 400 225.0 191.0–265.0 27.0
180 vs. 400 332.9 282.6–392.1
240 vs. 400 451.6 383.4–531.9
AUC0–T 2890.1 4385.0 6137.1 6789.6 120 vs. 400 42.6 39.3–46.2 13.2
180 vs. 400 64.6 59.6–70.0
240 vs. 400 90.4 83.4–98.0
AUC0–∞ 3254.9 4977.2 6763.2 7783.8 120 vs. 400 41.8 38.6–45.3 11.5
180 vs. 400 63.9 59.1–69.3
240 vs. 400 86.9 80.2–94.1

AUC area under the plasma concentration–time curve, AUC0-Re fTmax AUC from baseline through T max, AUC 0–T AUC from baseline through the last measured concentration, AUC 0–2h AUC from baseline through 2 h post-dose, AUC 0–∞ AUC extrapolated to infinity, AUC 0–T/∞ AUC0–T with respect to AUC0–∞, CI confidence interval, C max maximum observed plasma concentration, CV coefficient of variation, LSM least-square means, T max time to peak concentration, t ½ terminal half-life, λ Z apparent elimination rate constant

aValues are ng/ml for C max and ng·h/mL for AUCs

b n  =  11 for λZ, AUC0–∞, AUC0–T/∞, and t½

c n  =  12 for DFN-15 120 mg, n  =  14 for DFN-15 180 mg, n  =  12 for DFN-15 240 mg, and n  =  14 for celecoxib 400-mg oral capsules