Table 1.
Mean (s.d.) pharmacokinetic parameters for finrozole after single oral 3, 9 or 30 mg doses as tablets or solution in healthy male subjects.
| Finrozole | |||||
|---|---|---|---|---|---|
| 3 mg | 9 mg | 30 mg | |||
| Parameter | tablet | solution | tablet | solution | tablet |
| tmax (h) | 2.94 (1.29)* | 0.63 (0.23) | 2.50 (0.58)* | 0.71 (0.27) | 3.13 (1.33) |
| [95%CI: + 1.22, + 3.41] | [95%CI: + 1.20, + 2.37] | ||||
| Cmax (ng ml–1) | 2.11 (1.58)* | 6.22 (1.73) | 8.88 (3.28)* | 36.87 (17.09) | 18.20 (5.65) |
| [95%CI: −5.98, −2.23] | [95%CI: −44.12, −11.86] | ||||
| AUC(0,∞)(ng ml–1 h) | 13.25 (9.03) | 13.93 (3.79) | 57.68 (17.88)* | 75.54 (22.24) | 118.23 (45.69) |
| [95%CI: −5.32, + 3.96] | [95%CI: −27.61, −8.12] | ||||
| AUC(0,∞)/dose | 4.42 (3.01) | 4.64 (1.26) | 6.41 (1.99)* | 8.39 (2.47) | 3.94 (1.52) |
| [95%CI: −1.77, + 1.32] | [95% CI: −3.07, −0.90] | ||||
| t1/2,z (h) | 8.36 (4.48)* | 3.38 (3.31) | 7.85 (2.53)* | 2.86 (0.94) | 7.71 (1.65) |
| [95%CI: + 1.47, + 8.22] (1) | [95%CI: + 2.38, + 7.61] | ||||
| AUC(0,∞)−ratio | 88.69 (34.36) | 77.68 (13.51) | – | ||
| [95%CI: + 59.96, + 117.41] | [95%CI: + 65.19, + 90.17] | ||||
*
P <0.05, finrozole tablet vs solution at the 3 and 9 mg dose levels.
95% confidence intervals (CI) for the formulation (tablet vs solution) difference are given in brackets [].
1
Calculated for seven subjects, because elimination rate constant could not be estimated in one subject
AUC(0,∞)−ratio=tablet/solution.