Table 3.
Statistical analysis of dose proportionality of dose-normalized data using CI approach base on ANOVA model
| Pharmacokinetic parameter | Geometric LSM
|
Geometric LSM ratio
|
||
|---|---|---|---|---|
| 300 mg (n=10) | 150 mg (n=10) | Point estimate (300/150 mg) | 90% CI | |
| AUClast/dose (h⋅ng−1⋅mL−1⋅mg−1) | 175.67 | 172.14 | 1.0205 | 0.8928–1.1666 |
| Cmax /dose (ng·mL−1·mg−1) | 13.14 | 13.45 | 0.9767 | 0.8416–1.1335 |
| 450 mg | 150 mg | Point estimate | 90% CI | |
| (n=9) | (n=10) | (450/150 mg) | ||
| AUClast/dose (h·ng−1·mL−1·mg−1) | 170.56 | 172.14 | 0.9908 | 0.8636–1.1368 |
| Cmax /dose (ng·mL−1·mg−1) | 12.63 | 13.45 | 0.9389 | 0.8057–1.0941 |
| 600 mg | 150 mg | Point estimate | 90% CI | |
| (n=9) | (n=10) | (600/150 mg) | ||
| AUClast/dose (h·ng−1·mL−1·mg−1) | 174.55 | 172.14 | 1.0139 | 0.8838–1.1632 |
| Cmax /dose (ng·mL−1·mg−1) | 12.04 | 13.45 | 0.8949 | 0.7680–1.0429 |
Abbreviations: AUClast, area under the serum concentration-time curve from time zero to the time of the last measured concentration; Cmax, maximum serum concentration; LSM, least square mean.