Table 1.
Pharmacokinetic parameter | Group 1 (carbamazepine) (n = 9) | Group 2 (placebo) (n =10) | Difference (ratiod) Group 1 – Group 2 means (95% CI) | P value (Group 1 vs Group 2) |
---|---|---|---|---|
Day 3 | ||||
AUC(0,12 h) (ng ml−1 h) | 445 ± 155 | 532 ± 146 | 83.7% (62, 113) | 0.23 |
Cmaxa (ng ml−1) | 65 ± 25 | 76 ± 3 | 86.1% (61, 122) | 0.38 |
tmaxb (h) | 5 ± 3 | 6 ± 2 | −1.10 (−3.4, 1.1) | 0.30 |
λzb (h−1) | 0.160 ± 0.024 | 0.171 ± 0.026 | −0.011 (−0.035, 0.013) | 0.34 |
t½,zc (h) | 4.3 | 4.1 | – | – |
Day 28 | ||||
AUC(0,12 h) (ng ml−1 h) | 285 ± 79 | 495 ± 131 | 57.7% (44, 75) | <0.001 |
Cmaxa (ng ml−1) | 48 ± 13 | 79 ± 19 | 60.4% (47, 78) | <0.001 |
tmaxb (h) | 6 ± 1 | 6 ± 2 | 0.40 (−1.1, 1.9) | 0.57 |
λzb (h−1) | 0.211 ± 0.042 | 0.175 ± 0.046 | 0.037 (−0.006, 0.079) | 0.09 |
t½,zc (h) | 3.3 | 4.0 | – | – |
Ratio Day 28/Day3 | ||||
AUC(0,12 h) (ng ml−1 h) | 0.64 ± 0.20 | 0.93 ± 0.12 | – | – |
Cmaxa (ng ml−1) | 0.73 ± 0.20 | 1.04 ± 0.25 | – | – |
t½,zc (h) | 0.77 ± 0.13 | 1.06 ± 0.43 | – | – |
Geometric means and s.d.
Arithmetic means and s.d.
Calculated as ln 2/mean λz.
AUC(0,12 h) and Cmax were analysed on the log scale and back-transformed for calculation of the group 1 – group 2 ratio and 95% confidence limits of differences between means.