Table 3.
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 | ||||||
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, 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