Parameter | Ratio of Geometric LS Means (90% CI) |
---|
FKB327 PFS/FKB327 vial | FKB327 AI/FKB327 vial | FKB327 AI/FKB327 PFS |
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Primary |
AUC0-t (h*ng/mL) | 0.994 (0.877, 1.13) | 1.11 (0.976, 1.254) | 1.11 (0.981, 1.26) |
AUC0-∞ (h*ng/mL) | 0.967 (0.861, 1.09) | 1.04 (0.925, 1.16) | 1.07 (0.954, 1.20) |
Cmax (ng/mL) | 1.00 (0.918, 1.09) | 1.04 (0.957, 1.13) | 1.04 (0.957, 1.13) |
Secondary |
t1/2 (h) | 1.01 (0.880, 1.16) | 1.00 (0.877, 1.15) | 0.995 (0.868, 1.14) |
tmax (h) | 0 (−24.0, 0) | 0 (−24.0, 23.9) | 0 (0, 24.0) |
- AI indicates prefilled autoinjector; ANOVA analysis of variance; AUC0-t area under the serum concentration-time curve to the last detectable value; AUC0-∞ area under the serum concentration-time curve extrapolated to infinity; CI confidence interval; Cmax, peak serum concentration; LS least squares; PFS prefilled syringe; tmax maximum concentration; t1/2 elimination half-life; vial, vial with disposable syringe