Table 3.
Comparison of pharmacokinetic characteristics of empagliflozin in the paediatric population in this trial and adults 13 with Type 2 diabetes after single‐dose empagliflozin administration
| Population | Empagliflozin dose, mg | AUC0‐∞, nmol h/l | AUC0‐24, nmol h/l | Cmax, nmol/l | tmax *, h | t1/2, h | fe0‐24, % | CLR,0‐24, ml/min |
|---|---|---|---|---|---|---|---|---|
| Paediatric (n=8) | 10 | 1450 (17.2) | 1310 (18.9) | 211 (59.1) | 1.25 (0.97‐4.17) | 7.61 (27.0) | 18.4 (24.2) | 52.2 (23.8) |
| Adults 13 (n =16) | 10 | 1740 (16.4) | 1550 (16.2) | 309 (45.2) | 1.50 (1.00‐2.50) | 8.76 (13.0) | 12.5 (24.0) | 30.1 (25.1) |
| Paediatric (n =10) | 25 | 5250 (27.6) | 4720 (27.4) | 692 (57.3) | 1.78 (0.50‐4.00) | 8.09 (26.8) | 19.4 (15.4) | 40.0 (26.9) |
| Adults 13 (n =16) | 25 | 4340 (23.1) | 3930 (22.9) | 722 (20.0) | 1.50 (0.75‐2.00) | 8.24 (14.9) | 13.3 (24.5) | 32.4 (28.1) |
AUC0‐∞, area under the plasma concentration‐time curve from time 0 extrapolated to infinity; AUC0‐24, area under the plasma concentration‐time curve from time 0 to 24 h post dose; CLR,0‐24, renal clearance of the analyte from time 0 to 24 h post dose; Cmax, maximum observed plasma concentration; CV, arithmetic coefficient of variation; Fe0‐24, fraction of analyte eliminated in urine from time 0 to 24 h post dose; tmax, time from dosing until maximum observed concentration is reached in plasma; t1/2, terminal half‐life in plasma. For AUC0‐∞, AUC0‐24, Cmax, and t1/2, the arithmetic mean and %CV are given.
*For tmax, the median and range are given (instead of mean and %CV).