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Table 2 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

ParameterFKB327 vial
n = 65
FKB327 PFS
n = 63
FKB327 AI
n = 65
Primary
 AUC0-t (h*ng/mL)2,150,000 (54.7)2,140,000 (43.0)2,380,000 (36.5)
 AUC0-∞ (h*ng/mL)2,380,000 (39.1)c2,300,000 (39.5)b2,460,000 (38.7)c
 Cmax (ng/mL)3450 (31.4)a3450 (30.1)a3590 (27.9)a
Secondary
 AUC0-360h (h*ng/mL)999,000 (41.3)998,000 (32.4)1,080,000 (27.4)
 tmax (h)120 (72.0, 363)120 (48.0, 363)144 (48.0, 363)
 t1/2 (h)305 (47.9)c307 (49.7)b306 (42.1)c
 kel (h)0.00227 (47.9)c0.00225 (49.7)b0.00226 (42.1)c
  1. amedian (range); bn = 56; cn = 60
  2. AI indicates prefilled autoinjector; 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; AUC0-360h area under the serum concentration-time curve from zero to 360 h; Cmax peak serum concentration; kel elimination rate constant; PFS prefilled syringe; tmax maximum concentration; t1/2 elimination half-life; vial, vial with disposable syringe