Table 3.
Population | Study design | TBW (kg) | Age (years) | AUCa (mg × min/l) | CL/F (l/min) | V/F (l) | Ka (min−1) |
---|---|---|---|---|---|---|---|
Obese adolescents from this study | Fasted | 79.3 ± 13.9 | 14.5 ± 1.8 | AUC0–inf 460.5 ± 223 AUC0–8 316.5 ± 101.6 |
1.17b | 485b | 0.0248b |
Non-obese children [7] | Dinner | 33.3 ± 2.7 | 9.5 ± 0.1 | AUC0–12 816.2 ± 57.8 | 0.55 ± 0.55c | 185 ± 11.7d | 0.0175 ± 0.0045 |
Obese adolescents with T2DM [8] | Breakfast | 98 ± 25 | (12–16) | AUC0–inf 378.7 ± 1.6 | 1.32e | – | – |
Healthy adults [8] | Breakfast | 91 ± 21 | (20–45) | AUC0–inf 398 ± 1.7 | 1.26e | – | – |
Healthy adults and adults with T2DM [29] | – | 71 ± 14 89 ± 16 |
27 ± 6 56 ± 5 |
– | 1.27 ± 0.27 1.32 ± 0.11 |
559 ± 163 648 ± 13.8 |
– |
Obese adults [28] | Fasted | 114.6 ± 26.1 | 43.5 ± 11.7 | AUC0–inf 342 ± 108 | 1.46e | 114.6 ± 45.8f | – |
Values are expressed as mean ± standard deviation (range) unless specified otherwise
AUC0–12 AUC concentrations from 0 to 12 h after dose, AUC0–8 area under the curve concentrations from 0 to 8 h after dose, AUC0–inf AUC until infinity, CL/F oral clearance, Ka absorption rate constant, T2DM type 2 diabetes mellitus, TBW total body weight, V/F oral volume of distribution
aDose standardized (500 mg) AUC
bPopulation mean
cReported clearance of 0.33 ± 0.033 with fixed bioavailability of 60%
dReported volume of 111 ± 7 with fixed bioavailability of 60%
eCalculated by CL/F = dose/AUC
fReported weight normalized V/F of 1.0 ± 0.4 l/kg