Table 2.

Paromomycin PK following administration of paromomycin alone or WR 279,396 to adults on day 1 and day 20

Day, treatment, and statistica	Dose (g)	CumDoseb (g)	Cmax (ng/ml)	Tmax (h)	AUC0–24 (ng · h/ml)	t1/2 (h)	Cmax/Dc (1/ML)	AUC/Dd (h/ML)
Day 1
Paromomycin
No. of subjects	13	13	13	10	13	9	13	13
Mean value (% CV)	2.1 (69.8)	2.1 (69.8)	331 (112.2)	2.50 (38.9)	2,180 (120.2)	5.04 (118.4)	135 (90.7)	823.5 (99.0)
GeoMean value	1.7	1.7	79.1	2.32	278.7	3.50	44.3	156.0
WR 279,396
No. of subjects	13	13	13	9	13	6	13	13
Mean value (% CV)	2.6 (54.7)	2.6 (54.7)	131 (85.7)	2.89 (76.3)	975.6 (110.5)	4.15 (35.2)	56.6 (98.5)	344.3 (89.8)
GeoMean value	2.3	2.3	35.6	2.33	125.7	3.96	18.6	65.69
P value
Day 1 ANOVA, site			0.472		0.245	0.585	0.611	0.704
Day 1 ANOVA, treatment			0.478		0.841	0.597	0.353	0.500
Day 20
Paromomycin
No. of subjects	13	13	13	13	13	11	13	13
Mean value (% CV)	3.4 (50.4)	53.3 (40.1)	1,000 (74.8)	3.12 (73.0)	8,575 (84.8)	5.96 (43.5)	281 (51.5)	2,344 (53.3)
GeoMean value	3.0	48.6	751	2.52	6,173	5.53	252	2,070
WR 279,396
No. of subjects	13	13	13	12	13	12	13	13
Mean value (% CV)	3.4 (55.4)	57.8 (43.7)	660 (73.7)	2.46 (53.1)	6,037 (65.5)	6.94 (47.6)	211 (61.5)	1,926 (76.1)
GeoMean value	2.8	52.1	354	2.07	2,681	6.21	135	1,022
P value for day 20
ANOVA, site		0.208	0.103		0.490	0.097	0.166	0.136
ANOVA, treatment		0.645	0.235		0.533	0.310	0.209	0.299
P value for day 20 vs day 1, ANOVA	0.082		0.003		0.012	0.005	0.004	0.007

^aGeoMean, geometric mean.

^bCumulative dose.

^cC_max/D, C_max divided by administered dose of cream. ML, megaliter.

^dAUC/D, AUC_0–24 divided by administered dose of cream.