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Table 3 Summary of ANOVA for Pharmacokinetic Parameters

From: A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

ParameterRatio of Geometric LS Means (90% CI)
FKB327 PFS/FKB327 vialFKB327 AI/FKB327 vialFKB327 AI/FKB327 PFS
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)
  1. 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
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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