| PK Parameters |
Mean±SD (Range) N=25 |
|
Occasion-1
(N=25) |
IIV
(%CV) |
Occasion-2
(N=25) |
IIV
(%CV) |
IOV
(%CV) |
Residual variability |
Cmax
(ng/mL) |
5.3±4.1
(0.6-16.8) |
77.22 |
4.8±3.5
(0.6-15.7) |
73.22 |
43.87 |
17.60 |
AUClast
(ng*hr/mL) |
55.8±30.0
(7.1-128.0) |
53.83 |
50.6±30.6
(10.6-22.6) |
60.40 |
33.07 |
10.38 |
†AUCinf
(ng*hr/mL) |
61.4±27.9
(17.8-129.1) |
45.47 |
55.8±29.2
(13.5-125.0) |
52.42 |
24.11 |
5.65 |
†Kel
(1/hr) |
0.040±0.01
(0.03-0.06) |
27.56 |
0.04±0.01
(0.02-0.08) |
41.03 |
23.24 |
5.26 |
†Vd/F
(L) |
33.9±18.20
(7.19-77.22) |
53.70 |
38.3±29.34
(9.35-139.37) |
76.69 |
30.40 |
8.84 |
†CL/F
(mL/min) |
1.3±0.79
(0.46-3.61) |
59.85 |
1.5±1.04
(0.48-4.43) |
71.06 |
24.11 |
5.65 |
|
N - Number of observations
IIV - Inter-individual variability
IOV - Inter-occasion variability – intra-subject variability was considered as inter-occasion variability
† N=24, since subject no. 13 did not exhibit log-linear elimination in time vs concentration profile |
| Table 3: Mean obtained pharmacokinetic parameters and inter-occasion, inter-individual and residual variability for Trospium |
