Table 4: Pharmacokinetic parameters of LORATADINE following administration of single oral dose of Loratadine 10mg Oral Disintegrated Tablets (Test product) to 24 Volunteers.
Test
Subject Tmax Cmax AUClast AUCINF Lambda_z t1/2 MRTINF
A 1.5 1.3696 16.3635 19.9672 0.02779 24.9397 42.7288
B 0.5 3.14745 17.0303 20.5191 0.02994 23.1525 37.886
C 0.75 3.1156 15.73 19.0808 0.02906 23.8526 38.3215
D 1 3.12827 31.1266 33.1376 0.0411 16.8635 26.6466
E 0.75 8.66104 58.1602 67.5178 0.03641 19.037 32.1573
F 0.75 7.21098 56.5941 63.4714 0.02996 23.135 32.504
G 2 3.07894 31.5977 37.9853 0.0279 24.8443 39.8116
H 0.75 6.2269 43.4588 53.1368 0.03427 20.2268 37.4979
I 1 6.96263 34.8732 39.931 0.03873 17.8987 29.9915
J 1 6.86389 64.8857 73.267 0.03054 22.6941 33.2603
K 1.5 3.98689 37.3706 45.3272 0.03035 22.8413 37.5294
L 0.5 7.82417 65.3198 70.8808 0.03752 18.4723 27.5323
M 1 5.8808 33.1465 36.8415 0.04294 16.1412 26.0765
N 4 6.47711 77.1714 84.5555 0.03284 21.1064 26.7005
O 1 6.77925 77.3203 78.7683 0.05164 13.4228 20.7299
P 1.5 8.74915 98.9943 99.9767 0.05751 12.0527 19.5202
Q 2.5 6.76089 50.512 55.7743 0.03345 20.722 28.7109
R 0.5 4.08388 39.1155 43.7087 0.03189 21.7389 32.9819
S 0.333 5.8827 31.766 36.5155 0.03418 20.2787 33.1579
T 1.5 7.868 62.8452 73.5363 0.0326 21.2613 32.4357
U 2.5 4.579 59.569 64.8248 0.03557 19.4863 26.8492
V 0.333 6.81588 77.3222 82.101 0.04289 16.1595 22.5506
W 1 6.80975 60.6873 66.0357 0.03579 19.3665 26.9329
X 2.5 7.45377 33.9627 37.047 0.04021 17.2386 22.7106
Mean 1.27775 5.82152 48.9551 54.3295 0.03605 19.8722 30.6343
SD 0.87943 2.01278 21.9226 22.3423 0.0073 3.39929 6.28431
CV% 68.8268 34.5748 44.781 41.1237 20.2404 17.1058 20.514
Min 0.333 1.3696 15.73 19.0808 0.02779 12.0527 19.5202
Max 4 8.74915 98.9943 99.9767 0.05751 24.9397 42.7288
Median 1 6.619 46.9854 54.4556 0.03422 20.2527 31.0744