TABLE 1.
Pharmacokinetics of ITR: SOS versus F05a
| Form of ITR | Cmax (ng/ml) | Tmax (h) | t1/2 (h) | AUC0–96 (ng · h/ml) | AUC0–∞ (ng · h/ml) |
|---|---|---|---|---|---|
| SOS | 306.4 (97.4) | 5.0 | 22.1 | 5,550.2 (130.7) | 5,838.0 (130.4) |
| F05 | 314.7 | 5.0 | 22.0 | 4,247.5 | 4,475.8 |
| 90% CIb | 87.5–107.2 | 94.1–103.2 | 94.9–105.4 | 118.6–142.8 | 118.3–142.6 |
a
Reference is F05. All pharmacokinetic values except bioavailability are least-square means. Numbers in parentheses are bioavailabilities (indicated as percentages) of SOS relative to F05.
b
If the 90% CI is completely contained in the range of 80 to 120% of the reference formulation, bioequivalence can be declared with respect to the parameter tested. Thus, AUCs indicate that the formulations are not bioequivalent.