Table 4.
Pharmacokinetic Parameters of Ibandronate from PPR5 and Bonish 150 mg Tablets (n=6)
| Parameters | Test Formulation (PPR5) | Reference Formulation (Bonish 150 mg Tablets) | P-value |
|---|---|---|---|
| tmax (h) | 2±0.025 | 4±1.398 | 0.0001 |
| Cmax (ng/mL) | 653±0.097 | 493±0.237 | 0.0002 |
| t1/2 (h) | 11.69±2.025 | 6.139±1.142 | 0.0001 |
| AUC(0-t) (ng/mL.h) | 6899.25±3.467 | 3708.25±3.418 | 0.0001 |
| AUC(0-∞) (ng/mL.h) | 9058.83±5.612 | 4106.81±4.104 | 0.0004 |
| AUMC (ng/mL.h) | 149,523.18±3.676 | 40,051.83±3.412 | 0.0001 |
| MRT (h) | 16.50±1.296 | 9.75±0.379 | 0.0003 |