TABLE 2.

PK Parameters for Plasma d- Plus l-methylphenidate on Day 5 of a 5-day Dosing Schedule: PRC-063 and IR Methylphenidate (Study II)

	PRC-063 (100 mg; n = 15)	IR Methylphenidate (20 mg TID; n = 15)
AUC0–24, ng · h/mL, mean ± SD (CV)	230.86 ± 87.88 (38.07%)	153.81 ± 54.50 (35.44%)
AUC0–t*, ng · h/mL, mean ± SD (CV)	253.83 ± 105.07 (41.39%)	156.60 ± 58.13 (37.12%)
Cmax, ng/mL, mean ± SD (CV)	16.14 ± 5.03 (31.15%)	16.19 ± 5.55 (34.26%)
Cmax0–4, ng/mL, mean ± SD (CV)	12.63 ± 3.81 (30.16%)	10.35 ± 2.69 (25.99%)
Cmax8–16, ng/mL, mean ± SD (CV)	15.89 ± 5.11 (32.17%)	15.67 ± 5.69 (36.31%)
Cmin, ng/mL, mean ± SD (CV)†	3.27 ± 2.21 (67.55%)	0.86 ± 0.62 (71.92%)
Tmax, median (range), h	11.5 (2.0–16.0)	9.5 (5.0–11.0)
Tmax0–4, median (range), h	1.5 (1.0–2.5)	2.0 (1.5–2.5)
Tmax8–16, median (range), h	12.0 (8.5–16.0)	9.5 (9.0–11.0)
Fluctuation index, %, mean ± SD (CV)†	138.42 ± 29.75 (21.49%)	244.02 ± 33.64 (13.79%)

*t = 36 hours.

^†n = 14 (1 subject was excluded from calculation of summary statistics because no 24-hour sample was collected for the PRC-063 arm).