TABLE 2.
Statistical comparison of pharmacokinetic parameters for AS, DHA, and AQ following administration of a single oral dose of the test and reference products in Chinese healthy volunteersa
| Drug and metabolite parameters | GLSM ratio (test/reference) | 90% CI | Intrasubject CV% |
|
|---|---|---|---|---|
| Test | Reference | |||
| Artesunate | ||||
| Cmax (ng/ml) | 95.9 | 84.5–108.7 | 39.2 | 43.7 |
| AUC0-last (ng · h/ml) | 93.9 | 87.2–101.1 | 24.2 | 25.1 |
| AUC0-inf (ng · h/ml) | 94.2 | 87.2–101.8 | 24.9 | 25.8 |
| t1/2 (h) | 99.9 | 86.2–115.8 | ||
| Dihydroartemisinin | ||||
| Cmax (ng/ml) | 96.2 | 86.8–106.6 | 36.5 | 31.9 |
| AUC0-last (ng · h/ml) | 91.9 | 87.4–96.6 | 14.3 | 18.6 |
| AUC0-inf (ng · h/ml) | 91.9 | 87.5–96.5 | 18.2 | 13.7 |
| t1/2 (h) | 98.5 | 92.7–104.6 | ||
| Amodiaquine | ||||
| Cmax (ng/ml) | 95.0 | 86.7–104.1 | 30.6 | 30.2 |
| AUC0-last (ng · h/ml) | 100.0 | 93.5–107.0 | 20.8 | 21.8 |
| AUC0-inf (ng · h/ml) | 100.1 | 94.2–106.4 | 18.7 | 19.6 |
| t1/2 (h) | 102.7 | 97.8–107.9 | ||
a
The test and reference products were administered as 2× 100/270 mg ASAQ. GLSM ratio, geometric least square mean ratio of natural log transformed PK parameters; 90% CI, 90% confidence interval; intrasubject CV%, percent coefficient of variation of intrasubject variability. Results were calculated using SAS software for all subjects who completed the study per protocol (n = 31).