Table 4.
Comparison of the pharmacokinetics of ODF formulations from IBSA with film‐coated tablet formulation and ODT formulation, both from Pfizer (De Toni et al., 2018)
Film‐coated tablet formulation from Pfizer | ODT formulation from Pfizer | ODF formulation from IBSA | |
---|---|---|---|
Cmax (ng/mL) | 49 | 46 | 38 |
AUC (ng h/mL) | 6180 | 4623 | 5898 |
Tmax (ng/mL), meana | 95 | 90 | 70 |
Tonset (10 ng/mL)b | 13.5 | 25.5 | 40 |
Tonset (20 ng/mL)b | 21.5 | 39 | 57 |
Adverse effects | |||
Nasal congestion | 40% | 25% | 30% |
Flushing | 50% | 20% | 20% |
Headache | 35% | 30% | 5% |
Non‐fasting patients.
Derived from a figure of De Toni et al. study.