Table 3.
Pharmacokinetic parameter estimates
| Cmax (ng/ml) | AUC (ng*hr/ml) | |
|---|---|---|
| (a) Placebo | ||
| Mean (sd) | 10.0 (1.00) | < 0 (x) |
| Median | 10.0 | < 0 |
| CV % | 10.0 | - |
| (b) 400 mcg | ||
| Mean (sd) | 22.8 (9.9) | 427.1 (276.5) |
| Median | 21.0 | 435.5 |
| 95 % CI | (-25.5, 51.1) | (-79.6, 934.0) |
| (c) 800 mcg | ||
| Mean (sd) | 30.75 (8.4) | 567.5 (243.0)* |
| Median | 30.5 | 648.75 |
| 95 % CI | (-19.3, 60.8) | (37.6, 1100) |
| (d) 1200 mcg | ||
| Mean (sd) | 63.2 (27.8)* | 1077.9 (203.3)* |
| Median | 57.0 | 1055.3 |
| 95% CI | (14.9-91.5) | (571, 1580) |
Note:
P < .05: determined by comparison of each dose group (400mcg, 800mcg, and 1200mcg) to placebo group.