Table 1.
Pharmacokinetic parameters of metformin HCl and dapagliflozin l-proline obtained after oral administrations of reference and test formulations to healthy volunteers (mean ± S.D.).
| Parameters | Metformin HCl | Dapagliflozin l-Proline | ||
|---|---|---|---|---|
| Reference (n = 32) | Test (n = 32) | Reference (n = 32) | Test (n = 32) | |
| t1/2 (h) | 5.22 ± 1.62 | 4.93 ± 2.46 | 8.75 ± 3.88 | 8.94 ± 3.77 |
| Cmax (ng/mL) | 1183.72 ± 378.92 | 1235.03 ± 319.71 | 170.83 ± 42.85 | 166.88 ± 53.28 |
| Tmax (h) | 3.41 ± 0.71 | 3.28 ± 0.94 | 0.72 ± 0.19 | 0.79 ± 0.23 |
| AUClast (ng·h/mL) | 7453.69 ± 2012.66 | 7435.50 ± 1824.21 | 475.38 ± 122.51 | 480.66 ± 147.52 |
| AUCinf (ng·h/mL) | 7798.04 ± 2028.24 | 7801.86 ± 1796.19 | 501.20 ± 129.25 | 509.59 ± 153.19 |
| Vd/F (L) | 1048.83 ± 552.35 | 949.16 ± 579.11 | 258.93 ± 95.36 | 261.84 ± 93.46 |
| CL/F (L/h) | 137.74 ± 40.81 | 135.25 ± 33.23 | 21.27 ± 5.42 | 21.30 ± 6.08 |