Table 4.
Individual analytes | ||||
---|---|---|---|---|
Parameter | Glepaglutide | Parent | M1 | M2 |
AUClast (h × pmol/L) | 40,800 (35.3%) [15] | 37,100 (38.8%) [15] | 782 (103%) [15] | 1580 (108%) [15] |
AUCinf (h × pmol/L) | 44,200 (33.7%) [13] | 40,500 (39.8%) [12] | 1010 (70.4%) [14] | 2930 (59.3%) [9] |
Cmax (pmol/L) | 54,900 (46.3%) [15] | 54,100 (46.9%) [15] | 446 (84.5%) [15] | 419 (79.9%) [15] |
tmax (h), median (min-max) | 0.42 (0.28–0.58) [15] | 0.42 (0.28–0.58) [15] | 0.63 (0.35–1.02) [15] | 1.50 (1.25–3.00) [15] |
t1/2,z (h), mean (SD) | 10.4 (8.93) [13] | 11.7 (8.10) [12] | 1.2 (0.24) [15] | 2.6 (0.90) [14] |
CL (L/h) | 5.72 (39.8%) [12] | |||
Vss (L) | 14.0 (120%) [12] | |||
MRAUCinf | 0.0260 (97.3%) [11] | 0.0812 (94.2%) [8] |
Geometric mean (CV%) is presented unless otherwise specified. Numbers in square brackets denote the number of subjects included in the analysis
AUCinf area under the plasma concentration–time curve from time zero to infinity, AUClast area under the plasma concentration–time curve from time zero to the time of the last measurable concentration, CL clearance, Cmax maximum observed plasma concentration, CV coefficient of variation, h hours, max maximum, min minimum, MRAUCinf metabolite: parent ratio based on AUCinf, SD standard deviation, t1/2,z apparent plasma terminal elimination half-life, tmax time of the maximum observed plasma concentration, Vss volume of distribution at steady state