Table 3.
Parameter (Unit) | Treatment | N | Geometric LS Means | Ratio of Geometric LS Means (300 mg IV/Placebo IV) | 90%CI of the Ratio |
---|---|---|---|---|---|
AUC0‐t (μg·h/mL) | 300 mg IV | 32 | 708.8 | 1.068 | (1.028, 1.110) |
Placebo IV | 32 | 663.8 | |||
AUC0‐inf (μg·h/mL) | 300‐mg IV | 32 | 738.6 | 1.063 | (1.026, 1.100) |
Placebo IV | 32 | 695.2 | |||
Cmax (μg/mL) | 300‐mg IV | 32 | 179.4 | 1.031 | (0.996, 1.068) |
Placebo IV | 32 | 174.0 |
AUC0‐inf indicates area under concentration‐time curve from 0 to infinity; AUC0‐t, area under concentration‐time curve from 0 to last measurement; Cmax, peak concentration; IV, intravenous; LS, least‐squares; PK, pharmacokinetic; SBECD, sulfobutylether‐β‐cyclodextrin.