TABLE 3.
Similarity analysis results of primary PK parameters
| PK parameter geometric mean | GM | GMR a (%) | 90% CI (%) | CVw (%) | |
|---|---|---|---|---|---|
| RD12014 | Victoza | ||||
| C max (ng/ml) | 41.00 | 36.58 | 112.07 | (106.29, 118.18) | 15.7 |
| AUC0−last (h*ng/ml) | 1061.06 | 951.44 | 111.52 | (106.73, 116.53) | 13.0 |
| AUC0−inf (h*ng/ml) | 1080.49 | 974.52 | 110.87 | (106.37, 115.57) | 12.3 |
Note: Bioequivalence was declared if the 90% CIs were within the range of 80.00–125.00%. Test group: RD12014; reference group: Victoza.
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; CI, confidence interval; C max, maximum plasma concentration; CVw, within‐subject coefficient of variation; GM, geometric mean; GMR, geometric mean ratio; h, hour; ml, milliliter; ng, nanogram; PK, pharmacokinetic; SD, standard deviation.
a
Test‐to‐reference ratio of geometric means.