Table 5.
Bioequivalence Analysis of IV Fosnetupitant 235 mg (Test Formulation) and Oral Netupitant 300 mg (Reference Formulation)
| Netupitant Parameter | Treatment | GLSM (Antilog) | Test (IV)/Reference (Oral) GLSM Ratio, % | 90%CI (Lower–Upper Limits) |
|---|---|---|---|---|
| AUC0‐last, ng • h/mL | IV fosnetupitant (Test) | 11876 (n = 30) | 94.1 | 87.6–101.1 |
| Oral NEPA (Reference) | 12621 (n = 30) | |||
| AUC0‐inf, ng • h/mL | IV fosnetupitant (Test) | 13290 (n = 26) | 88.2 | 82.3–94.5 |
| Oral NEPA (Reference) | 15073 (n = 21) |
AUC0‐inf, area under the plasma concentration–time curve from time 0 to infinity; AUC0‐last, area under the plasma concentration–time curve from time 0 to the time of last measurable concentration; GLSM, geometric least squares means; IV, intravenous.
For the bioequivalence assessment, the AUC0‐inf values included in the analysis were only those with percentage extrapolation from tlast to infinity <20%.