Table 4.
Summary of Statistical Analysis Results: (1) Comparison of Plasma Ubrogepant PK Parameters When Administered Alone and in Combination With Sumatriptan; (2) Comparison of Plasma Sumatriptan PK Parameters When Administered Alone and in Combination With Ubrogepant in Healthy Adult Participants
| Statistical Analysis | PK Parameter | Geometric LSM | Geometric Mean Ratio (Test/Reference) | 90% Lower CI | 90% Upper CI | |
|---|---|---|---|---|---|---|
| Test | Reference | |||||
| Plasma ubrogepant (ubrogepant = reference; ubrogepant + sumatriptan = test) | C max, ng/mL | 284.00 | 373.13 | 0.76 | 0.69 | 0.85 |
| AUC0‐ t, ng•h/mL | 1516.11 | 1496.54 | 1.01 | 0.94 | 1.09 | |
| AUC0‐∞, ng•h/mL | 1538.91 | 1520.52 | 1.01 | 0.94 | 1.09 | |
| Plasma sumatriptan (sumatriptan = reference; sumatriptan + ubrogepant = test) | C max, ng/mL | 50.72 | 53.06 | 0.96 | 0.85 | 1.08 |
| AUC0‐ t, ng•h/mL | 246.14 | 250.00 | 0.98 | 0.92 | 1.05 | |
| AUC0‐∞, ng•h/mL | 259.13 | 259.52 | 1.00 | 0.94 | 1.06 | |
AUC0‐∞ = area under the plasma drug concentration vs time curve from time 0 to infinity; AUC0‐ t = area under the plasma drug concentration vs time curve from time 0 to time t; C max = maximum plasma drug concentration; LSM = least squares mean; PK = pharmacokinetic.