TABLE 2.

Summary of PK parameters^a

Parameter	Value for group			P value
	Standard dose, oral (n = 17)	High dose, oral (35 mg/kg) (n = 15)	i.v. (20 mg/kg) (n = 14)
AUC0–24 (μg · h/ml)b				<0.001c
Geometric mean	42.9e	295.2	206.5
95% CI	24.5–75.0	189.9–458.8	154.6–275.8
Range	7.4–152.1	106.4–673.7	68.5–426.7
Ratio to standard dose		6.9	4.8
Cmax (μg/ml)				<0.001c
Geometric mean	6.9e	34.7	38.6
95% CI	5.2–9.2	25.2–47.8	31.2–47.6
Range	2.4–18.1	7.7–66.0	20.2–74.0
Ratio to standard dose		5.0	5.6
Median Tmax (h) (range)	2 (1–6)	3 (2–8)	1 (0.5–2)e	<0.001d
Median half-life (h) (range)	3.2 (2.6–13.3)	4.9 (2.1–21.6)e	2.6 (2.2–5.4)	0.01c
CL (liters/h)b				0.008c
Geometric mean	14.0e	7.4	6.6
95% CI	8.1–24.3	4.6–11.8	4.9–8.6
Range	4.9–100.7	2.2–21.4	3.9–17.5
%CV	124.8	66.8	52.4
V (liters)				0.01c
Geometric mean	72.9	55.2	27.8
95% CI	37.2–142.9e	26.3–116.8	20.1–38.3
Range	23.6–191.8	21.2–116.7	13–84.3
%CV	184.2	150.9	59.8

^aCI, confidence interval; %CV, percent coefficient of variation; V, volume of distribution.

^bMissing from 11 participants with unsuccessful intensive PK sampling and for whom there were not at least two observations in the elimination phase (standard dose, n = 5; high oral dose, n = 5; intravenous, n = 1).

^cANOVA after log transformation, with linear regression for pairwise comparisons.

^dKruskal-Wallis test.

^eComparator.