Table 1.
Mean (s.d.) pharmacokinetic parameters of tropisetron in 18 healthy volunteers following oral administration of a capsule containing 5 mg tropisetron and intravenous bolus injection of 2 mg tropisetron, respectively.
| Parameter | Ampoule | Capsule | 95% CI on the difference | P value |
|---|---|---|---|---|
| Dose (mg) | 2 | 5 | ||
| Cmax (ng ml−1) | 15.1 (7.3)(1) | 3.46 (1.35) | 8.05, 15.4 | < 0.001 |
| tmax (h) | NA | 2.6 (1.0) | ||
| t1/2 (h) | 5.6 (1.7)(2) | 5.7 (1.9) | −0.29, 0.53 | 0.54 |
| AUC(0,∞) (ng ml−1 h) | 20.7 (7.5) | 32.9 (18.8) | 6.09, 18.4 | < 0.001 |
| Vss (l) | 678 (106) | NA | ||
| CL (ml min−1) | 1800 (579) | NA | ||
| F | 1.00 | 0.60 (0.20) |
1) Obtained by log-linear regression of the first two data points to the time of administration. The concentrations were 7.42 (1.82) ng ml−1 at the first sampling time after 5 min. 2) Initial distribution half-life 5.9 (2.2) min.
Cmax maximum concentration, tmax time of Cmax, t1/2 terminal plasma-half life, AUC(0,∞) area under the plasma concentration-time curve from zero to infinity, Vss steady state volume of distribution, CL total body clearance, NA not applicable, F bioavailability, CI confidence interval on the differences.