TABLE 2.
Summary of PK parameters of RD12014 and Victoza
| PK parameter arithmetic mean (SD) [CV%] | RD12014 (n = 49) | Victoza (n = 49) |
|---|---|---|
| C max (ng/ml) | 42.11 (9.868) [23.43] | 37.58 (9.025) [24.01] |
| AUC0−last (h*ng/ml) | 1084.8130 (225.2798) [20.77] | 967.8264 (183.0252) [18.91] |
| AUC0−inf (h*ng/ml) | 1103.7647 (225.1409) [20.40] | 990.1840 (181.6512) [18.35] |
| T max (h) | 11 (8–14.017) | 11 (8–24) |
| t 1/2 (h) | 9.8677 (1.2213) [12.38] | 10.3209 (1.8196) [17.63] |
| CL/F (ml/h) | 567.7798 (126.3296) [22.25] | 626.3771 (116.5173) [18.60] |
| V d/F (ml) | 8060.3928 (1978.2818) [24.54] | 9363.2055 (2624.9996) [28.04] |
| λ z (1/h) | 0.0713 (0.0090) [12.63] | 0.0689 (0.0103) [14.94] |
Note: Data are presented as arithmetic mean (SD) [CV%] except T max are presented as median (minimum‐maximum).
Abbreviations: AUC0−last, area under the concentration‐time curve from time 0 to the time of the last quantifiable concentration; AUC0−inf, area under the concentration‐time curve from time 0 to infinity; CL/F, apparent total oral clearance; C max, maximum plasma concentration; h, hour; ml, milliliter; ng, nanogram; PK, pharmacokinetic; SD, standard deviation; t 1/2, elimination half‐life time; T max, time to maximum plasma concentration; V d/F, apparent volume of distribution based on the terminal phase; λ z, elimination rate constant.