Table 3.
Additional Plasma Glucagon Pharmacokinetic Parameters—Clearance (CL/F), Volume of Distribution (Vext/F), and Half-Life (t1/2)—After Glucagon as GAI or G-PFS in Study A. These Parameters Were not Determined After Glucagon as GVS or G-PFS in Study B. Bioequivalence was Confirmed When 90% CIs of Geometric Mean Estimates for G-PFS/GAI X 100% were Between 80% and 125%.
| Geometric mean estimate (SE) CL/F (mL/min) | |
|---|---|
| GAI | G-PFS |
| 6011.3 (37 875.4) | 5636.3 (35 513.0) |
| G-PFS/GAI (%; 90% CI) | |
| 93.76 (6.35; 83.57, 105.20) | |
| Geometric mean estimate (SE) Vext/F (mL) | |
| GAI | G-PFS |
| 1996.3 (31 136.3) | 1625.4 (25 351.0) |
| G-PFS/GAI (%; 90% CI) | |
| 81.42 (14.46; 60.21, 110.10) | |
| Geometric mean estimate (SE) t1/2 (min) | |
| GAI | G-PFS |
| 38.3 (181.0) | 35.5 (167.6) |
| G-PFS/GAI (%; 90% CI) | |
| 92.61 (5.40; 83.88, 102.26) | |
Abbreviations: GAI, glucagon autoinjector; G-PFS, glucagon prefilled syringe; GVS, glucagon vial and syringe kit; CI, confidence interval; SE, standard error.