Table 5.
Mean pharmacokinetic parameters of sibutramine, N-des methyl sibutramine, and N-di des methyl sibutramine in 40 healthy human volunteers after oral administration of 15 mg test and reference products (mean±SD).
| Pharmacokinetic parameter | Sibutramine |
N-des methyl sibutramine |
N-di des methyl sibutramine |
|||
|---|---|---|---|---|---|---|
| Test | Reference | Test | Reference | Test | Reference | |
| Cmax (pg/mL) | 4065.4±1481.2 | 4368.5±1654.4 | 4027.8±1420.6 | 4067.7±1451.9 | 6724.4±2341.2 | 6579.8±2294.6 |
| AUC0–t (pg h/mL) | 18,566.2±729.3 | 22,168.1±862.1 | 85,931.9±2898.0 | 93,405.9±3322.5 | 174,389.8±6977.7 | 182,500.9±698.5 |
| AUC0–∞ (pg h/mL) | 19,560.2±782.1 | 23,296.9±934.5 | 92,464.1±3121.0 | 100,736.1±3402.4 | 184,885.7±7432.4 | 194,500.9±8326.3 |
| tmax (h) | 1.5 | 1.5 | 6.0 | 6.0 | 6.0 | 6.0 |
| t1/2 | 3.7 | 3.6 | 27.2 | 25.5 | 23.9 | 23.6 |
AUC0–∞: Area under the curve extrapolated to infinity.
AUC0–t: Area under the curve up to the last sampling time.
Cmax: The maximum plasma concentration.
tmax: The time to reach peak concentration.