Table 3.
Subj No. | Cmax (ng/ml) | Cmax/Dose1 | AUC0–32 (ng.h/ml) | AUC0–32/Dose1 | AUC0-∝ (ng.h/ml) | AUC0-∝/Dose1 | Tmax (h) | t1/2 (h) | ||||||||
B | C | B | C | B | C | B | C | B | C | B | C | B | C | B | C | |
1 | 90.41 | 151.49 | 8.60 | 6.71 | 954.82 | 1950.40 | 90.85 | 86.42 | 1040.69 | 2248.09 | 99.02 | 99.61 | 6 | 6 | 8.46 | 9.92 |
2 | 68.08 | 124.90 | 6.48 | 5.53 | 693.31 | 1821.17 | 65.97 | 80.69 | 739.89 | 1941.50 | 70.40 | 86.02 | 1 | 8 | 7.62 | 7.42 |
3 | 149.53 | 301.34 | 14.23 | 13.35 | 1801.34 | 4392.34 | 171.39 | 194.61 | 1989.66 | 5048.92 | 189.31 | 223.70 | 8 | 8 | 8.25 | 9.37 |
4 | 212.94 | 516.77 | 20.26 | 22.90 | 1979.53 | 5541.88 | 188.35 | 245.54 | 2140.25 | 6175.55 | 203.64 | 273.62 | 6 | 6 | 8.10 | 8.93 |
5 | 96.95 | 220.38 | 9.22 | 9.76 | 1281.58 | 2478.42 | 121.94 | 109.81 | 1423.11 | 3072.33 | 135.41 | 136.12 | 8 | 10 | 9.73 | 12.40 |
6 | 96.57 | 301.62 | 9.19 | 13.36 | 1277.75 | 2776.28 | 121.57 | 123.01 | 1483.87 | 2972.50 | 141.19 | 131.70 | 10 | 6 | 10.10 | 7.74 |
7 | 223.77 | 371.31 | 21.29 | 16.45 | 3184.25 | 5260.83 | 302.97 | 233.09 | 4022.02 | 6003.94 | 382.69 | 266.01 | 4 | 8 | 12.60 | 9.58 |
8 | 110.60 | 193.01 | 10.52 | 8.55 | 948.75 | 2217.44 | 90.27 | 98.25 | 998.31 | 2370.24 | 94.99 | 105.02 | 6 | 6 | 5.07 | 8.41 |
9 | 54.86 | 183.88 | 5.22 | 8.15 | 425.80 | 1481.47 | 40.51 | 65.64 | 527.69 | 1500.60 | 50.21 | 66.49 | 4 | 6 | 4.41 | 4.80 |
10 | 69.95 | 214.54 | 6.66 | 9.51 | 773.90 | 1856.73 | 73.63 | 82.27 | 789.07 | 1940.05 | 75.08 | 85.96 | 6 | 6 | 5.34 | 6.63 |
11 | 105.13 | 217.57 | 10.00 | 9.64 | 1128.81 | 3121.71 | 107.40 | 138.31 | 1177.74 | 3208.73 | 112.06 | 142.17 | 6 | 8 | 6.32 | 5.27 |
12 | 117.61 | 345.31 | 11.19 | 15.30 | 871.60 | 2591.36 | 82.93 | 114.81 | 914.46 | 2631.99 | 87.01 | 116.61 | 4 | 6 | 5.35 | 5.05 |
Mean | 116.37 | 261.84ND | 11.07 | 11.60 | 1276.79 | 2957.50ND | 121.48 | 131.04 | 1437.23 | 3259.54ND | 136.75 | 144.42 | 5.75 | 7.00 | 7.61 | 7.96 |
SD | 53.80 | 110.68 | 5.12 | 4.90 | 746.04 | 1372.13 | 70.98 | 60.79 | 949.02 | 1599.34 | 90.30 | 70.86 | 2.34 | 1.35 | 2.44 | 2.28 |
1Pharmacokinetic parameters adjusted for oral administered dose. ND = statistical analysis was not performed due to differences in oral administered doses between both preparations.