Table 4.
6-Week toxicity study |
||||||||
---|---|---|---|---|---|---|---|---|
Males |
Females |
|||||||
Dose (mg/kg) | ||||||||
0 |
30 |
100 |
300 |
0 |
30 |
100 |
300 |
|
No. animals/group | ||||||||
5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | |
ALP (U/L) | Pre-study (week 2) | |||||||
582 ± 182.2 | 517 ± 151.0 | 680 ± 118.8 | 702 ± 260.7 | 442 ± 60.6 | 428 ± 82.9 | 489 ± 146.5 | 513 ± 76.0 | |
Day 6 | ||||||||
447 ± 122.0 | 582 ± 240.7 | 1,182 ± 343.4* | 1,536 ± 559.6*** | 373 ± 64.6 | 485 ± 114.6 | 891 ± 302.6*** | 1,284 ± 337.3*** | |
Day 37a | ||||||||
551 ± 140.3 | 623 ± 209.6 | 818 ± 186.0 | 1,076 ± 596.2 | 433 ± 80.9 | 522 ± 104.6 | 819 ± 278.5* | 852 ± 194.5** |
39-Week toxicity study |
||||||||
---|---|---|---|---|---|---|---|---|
Males |
Females |
|||||||
Dose (mg/kg) | ||||||||
0 |
15 |
75 |
200 |
0 |
15 |
75 |
200 |
|
No. animals/group | ||||||||
6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | |
ALP (U/L) | Pre-study (week 2) |
|||||||
403 ± 103.2 |
340 ± 46.3 |
309 ± 84.6 |
293 ± 57.6 |
178 ± 48.2 |
180 ± 39.8 |
166 ± 50.0 |
154 ± 30.3 |
|
Pre-study (week 1) | ||||||||
421 ± 110.1 |
335 ± 30.7 |
308 ± 92.2 |
314 ± 50.9 |
176 ± 48.0 |
174 ± 48.1 |
166 ± 48.0 |
142 ± 29.4 |
|
Day 275b | ||||||||
316 ± 92.9 | 284 ± 62.9 | 344 ± 89.3 | 459 ± 113.6* | 172 ± 38.5 | 183 ± 30.2 | 251 ± 58.6 | 250 ± 58.0* |
All findings reversed by end of 4-week recovery period.
All findings reversed by end of 13-week recovery period.
P ≤ 0.05, **P ≤ 0.01, ***P ≤ 0.001.