Table 2 % Ratio of untransformed data (Artefan® to Coartem ® ) and a comparison of data obtained by Norvatis
Primary Parameter | Artefan ® | Coartem ® | P value | % Ratio of test to reference | Norvatis Data on file (Riamet) |
|---|---|---|---|---|---|
Arithmetic mean ± SD | Arithmetic mean ± SD | Arithmetic mean | |||
(*) | (*) | ||||
Tmax (h) | 6.11±2.698 | 6.2±2.2 | 0.8950 | - | 6 – 8 |
Cmax (ng/ml) | 4206.9±2942.5 (3144.0) | 4438.81±2548.432 (3742.267) | 0.7836 | 84.0 | 5100-9800 |
AUC0-168 (ng.h/ml) | 123758.9±83527.5 (93175.97) | 135430.7±86814.8 (109729.0) | 0.6612 | 84.5 | - |
AUC0-∞ (ng.h/ml) | 138189.7±94959.8 (102441.5) | 149530.2±95109.4 (121576.3) | 0.7022 | 84.3 | 108000- 243000 |