Table 2.
Dose proportionality analysis of ST-246 plasma PK parameter estimates (PK population)
| Variable at day 14 | Geometric meana |
90% CIb |
|||
|---|---|---|---|---|---|
| Test (600 mg) | Ref (400 mg) | Ratio (%)c (test/ref) | Lower | Upper | |
| ln (Cmax/dose) | 2.4 | 3.0 | 79.8 | 69.4 | 91.7 |
| ln (AUCτ/dose) | 22.8 | 28.3 | 80.7 | 69.9 | 93.1 |
| ln (Cmax/dose)d | 2.4 | 2.9 | 83.6 | 74.0 | 94.5 |
| ln (AUCτ/dose)d | 23.0 | 27.1 | 84.9 | 74.7 | 96.6 |
a
Geometric mean for test formulation (test; 600 mg) and reference formulation (ref; 400 mg) based on least-squares mean of log-transformed parameter values. For the test formulation, n = 44; for ref, n = 43.
b
Ninety percent confidence interval: two products are considered bioequivalent if the 90% CI of the relative mean Cmax and AUCτ of the test to reference are within 80% to 125%.
c
Ratio (%) = geometric mean value (test)/geometric mean value (ref).
d
Body weight-normalized parameter derived by multiplying the parameter by (observed body weight/median body weight [78.6 kg]).