Figure 1.
Figure 2.
Figure 3.
Statistical comparisons of metformin pharmacokinetic parameters_
| Primary PK parameter | Number of subjects | Intrasubject CV | Geometric LS means | Ratio | 90% Confidence limits | Power | ||
|---|---|---|---|---|---|---|---|---|
| Test product (Sensityn®) | Reference product (Galvusmet®) | Lower | Upper | |||||
| Cmax | 36 | 13.12% | 1398.75 | 1439.77 | 97.15 | 92.22 | 102.34 | 1.0000 |
| AUC0-t | 36 | 11.36% | 12,936.80 | 13,158.66 | 98.31 | 93.97 | 102.85 | 1.0000 |
| AUC0-∞ | 35 | 10.99% | 13,470.20 | 13,850.76 | 97.25 | 93.03 | 101.66 | 1.0000 |
Statistical comparisons of vildagliptin pharmacokinetic parameters_
| Primary PK parameter | Number of subjects | Intrasubject CV | Geometric LS means | Ratio | 90% Confidence limits | Power | ||
|---|---|---|---|---|---|---|---|---|
| Test product (Sensityn®) | Reference product (Galvusmet®) | Lower | Upper | |||||
| Cmax | 36 | 19.91% | 73.87 | 71.09 | 103.90 | 96.05 | 112.40 | 0.9981 |
| AUC0-t | 36 | 10.12% | 354.19 | 348.77 | 101.55 | 97.55 | 105.72 | 1.0000 |
| AUC0-∞ | 33 | 8.32% | 375.66 | 369.50 | 101.67 | 98.20 | 105.25 | 1.0000 |
Summary of metformin pharmacokinetic parameters_
| Pharmacokinetic parameter | Test product (Sensityn®) | Reference product (Galvusmet®) |
|---|---|---|
| Cmax (ng/ml) | 1448.13 ± 397.346 | 1479.84 ± 348.938 |
| AUC0-t (h*ng/ml) | 13,340.49 ± 3305.003 | 13,597.70 ± 3486.835 |
| AUC0-∞ (h*ng/ml) | 13,853.49 ± 3331.352 | 14,153.50 ± 3784.388 |
| Thalf (h) | 4.28 ± 0.519 | 4.52 ± 1.030 |
| Kelimination, λz (h−1) | 0.1640 ± 0.01948 | 0.1593 ± 0.02752 |
| AUC_%Extrap_obs | 3.41 ± 3.254 | 3.63 ± 3.095 |
| Test product (Sensityn®) | Reference product (Galvusmet®) | |
| Tmax(h) | 4.00 ± 1.708 (1.00–8.00) | 4.50 ± 1.331 (0.75–6.00) |
Demographic data (N = 36)_
| Parameter | Age (years) | Height (m) | Weight (kg) | BMI (kg/m2) |
|---|---|---|---|---|
| Mean | 29.0 | 1.74 | 76.0 | 24.90 |
| SD | 7.8 | 0.05 | 9.6 | 2.97 |
| Min | 18.0 | 1.62 | 58.0 | 20.30 |
| Max | 45.0 | 1.84 | 92.0 | 29.70 |
Summary of vildagliptin pharmacokinetic parameters_
| Pharmacokinetic parameter | Test product (Sensityn®) | Reference product (Galvusmet®) |
|---|---|---|
| Cmax (ng/ml) | 76.54 ± 20.606 | 73.99 ± 21.526 |
| AUC0-t (h*ng/ml) | 358.56 ± 57.756 | 355.27 ± 69.553 |
| AUC0-∞ (h*ng/ml) | 378.17 ± 62.279 | 369.66 ± 68.677 |
| Thalf (h) | 2.22 ± 0.735 | 2.03 ± 0.567 |
| Kelimination, λz (h−1) | 0.3396 ± 0.09300 | 0.3706 ± 0.11124 |
| AUC_%Extrap_obs | 4.47 ± 5.142 | 3.19 ± 2.993 |
| Test product (Sensityn®) | Reference product (Galvusmet®) | |
| Tmax (h) | 2.50 ± 1.553 (0.75–8.00) | 2.50 ± 1.405 (0.50–5.00) |