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. 2017 Jul 29;57(2):151–176. doi: 10.1007/s40262-017-0570-0

Table 3.

Paromomycin: primary and secondary pharmacokinetic parameters

Study Patients Weight (kg) Daily dose Sampling day C max (µg/mL) C trough (µg/mL) t max (h) k a (h−1) V d/F (L) CL/F (L/h) AUC (mg·h/mL) t ½ (h)
Compartmental
 Kanyok et al. [36] Healthy volunteers
12 mg/kg 68.2±14.0 12 mg/kg (9 mg/kg base), single dose Single dose 21.6 ± 2.3 <LLOQ 1.19 ± 0.46 6.27 ± 4.41 0.35±0.04b,c 7.1 ± 0.78d AUC: 86.3 ± 15.0 2.21 ± 0.17
15 mg/kg 70.7±13.0 15 mg/kg (11 mg/kg base), single dose Single dose 23.4 ± 3.9 <LLOQ 1.51 ± 0.40 2.65 ± 1.29 0.41 ± 0.06b,c 7.6 ± 1.94d AUC: 104.5 ± 26.3 2.64 ± 0.82
 Kshirsagar et al. [38] Visceral leishmaniasis patients 35.5±11.8a 15 mg/kg (11 mg/kg base), 21 days Day 1 20.5 ± 7.01 4.53 ± 6.71 NA 2.11 (7.68%)e 15.3 (2.27%)e 4.06 (3.05%)e
IIV: 30.7%
NA 2.62
Day 21 18.3 ± 8.86 1.31 ± 4.16

Data given as mean ± standard deviation, unless indicated otherwise

AUC area under the concentration–time curve, AUC 24 AUC from time zero to 24 h, AUC AUC from time zero to infinity, CL clearance, C max peak plasma concentration, C trough trough plasma concentration 24 h after dose, F bioavailability, IIV inter-individual variability, k a absorption rate constant, <LLOQ below lower limit of quantitation, NA not available, t ½ plasma elimination half-life, t max time to C max, V d volume of distribution

aNot provided on poster [38], but provided for 501 patients included in clinical results of trial [33]: used as proxy for 448 of these 501 patients included in population pharmacokinetic model

b V β, apparent volume of distribution during the β-elimination phase

cPer kg

dPer 1.73 m2, reported as 117.7 and 126.0 mL/min, converted to L/h

eMean (% standard error)