Table 4.
Pharmacokinetic parameters after a single oral dose of LC
| Parameter | Age groups | |
|---|---|---|
| < 12 yearsa (n = 5) |
12–17 yearsa (n = 15) |
|
| AUC0–inf (h·ng/mL) | ||
| n | 1 | 10 |
| Geometric mean (CV%) | 1.93 (N/A) | 6.64 (51.41) |
| AUC0–48 (h·ng/mL) | ||
| n | 2 | 12 |
| Geometric mean (CV%) | 1.96 (39.73) | 6.03 (110.88) |
| AUClast (h·ng/mL) | ||
| n | 5 | 15 |
| Geometric mean (CV%) | 2.36 (40.16) | 5.59 (109.48) |
| Cmax (ng/mL) | ||
| n | 5 | 15 |
| Geometric mean (CV%) | 0.20 (43.59) | 0.43 (131.56) |
| tmax (h) | ||
| n | 5 | 15 |
| Median (min, max) | 8.00 (3.00, 23.87) | 5.00 (2.97, 12.00) |
| t1/2 (h) | ||
| n | 1 | 10 |
| Geometric mean (CV%) | 8.83 (N/A) | 17.07 (66.91) |
| CL/F (L/h) | ||
| N | 1 | 10 |
| Geometric mean (CV%) | 258,644.20 (N/A) | 150,545.92 (95.06) |
| Vz/F (L) | ||
| N | 1 | 10 |
| Geometric mean (CV%) | 3,295,611.00 (N/A) | 3,706,259.60 (51.46) |
| λz | ||
| N | 1 | 10 |
| Geometric mean (CV%) | 0.08 | 0.04 |
Data are presented for patients from pharmacokinetic set 1, which included all patients from safety analysis set 1 who had at least one measurable plasma concentration of LC post-dose who received a single oral dose of LC during part 1 of the study, stratified by age. For patients who had missing central laboratory data, local laboratory data were used, if available; otherwise, patients were excluded from relevant analyses
a Patients aged < 12 years and patients 12–17 years received a single dose of 500 mg and 1000 mg of LC, respectively
λz first-order rate constant associated with the terminal (log-linear) portion of the curve, AUC0–48 area under the curve from the time of dosing to 48 h after dosing, AUC0–inf area under the curve extrapolated to infinity, calculated using the last measurable concentration, AUClast area under the curve from the time of dosing to the last measurable concentration, CL/F total body clearance for extravascular administration divided by the fraction of dose absorbed, Cmax maximum observable plasma concentration, CV% percentage coefficient of variation, LC lanthanum carbonate, N/A not available, t1/2 terminal half-life; tmax time of maximum observed plasma concentration, Vz/F volume of distribution associated with the terminal slope after extravascular administration divided by the fraction of dose absorbed