Table 2. Pharmacokinetic parameters of fenofibric acid after the single-dose administration of the 135 mg capsule and the 110 mg enteric-coated tablet under fasting and fed conditions.
| Parameter | Fasting study (n = 53) | Fed study (n = 51) | ||
|---|---|---|---|---|
| 135 mg capsule | 110 mg enteric-coated tablet | 135 mg capsule | 110 mg enteric-coated tablet | |
| Cmax (ng/mL) | 14,598.4 ± 2,285.6 (15.7) | 13,532.7 ± 2,590.5 (19.1) | 8,525.2 ± 2,236.8 (26.2) | 9,650.7 ± 2,596.0 (26.9) |
| Cmax/Dose (ng/mL/mg) | 108.1 ± 16.9 | 123.0 ± 23.6 | 63.1 ± 16.6 | 87.7 ± 23.6 |
| AUClast (h∙ng/mL) | 223,397.1 ± 56,822.1 (25.4) | 193,548.8 ± 50,858.7 (26.3) | 164,757.3 ± 49,494.7 (30.0) | 167,595.3 ± 40,274.9 (24.0) |
| AUClast/Dose (ng/mL/mg) | 1,654.8 ± 420.9 | 1,759.5 ± 46.2 | 1,220.4 ± 366.6 | 1,523.6 ± 366.1 |
| AUCinf (h∙ng/mL) | 245,345.8 ± 73,141.7 (29.8) | 213,019.2 ± 65,346.1 (30.7) | 184,174.4 ± 55,092.0 (29.9) | 181,393.0 ± 48,733.9 (26.9) |
| T1/2 (h) | 20.4 ± 4.2 (20.4) | 19.9 ± 4.2 (21.2) | 19.1 ± 4.0 (21.1) | 17.8 ± 3.5 (19.9) |
| CL/F (mL/h) | 594.7 ± 155.7 (26.2) | 564.1 ± 163.7 (29.0) | 793.4 ± 226.8 (28.6) | 650.0 ± 176.4 (27.1) |
| Tmax (h) | 2.5 (2.0–5.0) | 3.5 (2.0–12.0) | 5.0 (0.0–12.0) | 8.0 (3.0–24.12) |
Values are expressed as arithmetic mean ± standard deviation (coefficient of variation), except for Tmax, which is shown as median (minimum-maximum).
Cmax, maximum plasma concentration; AUClast, area under the concentration-time curve to the last measured concentration over the limit of quantitation; AUCinf, area under the concentration-time curve from dosing to time infinity; T1/2, terminal half-life; CL/F, apparent clearance; Tmax, time to reach Cmax.