Table 2.
Main pharmacokinetic parameters (n = 22)
| AUCτ (pg × h/ml)a | C max (pg/ml)a | t max (h)b | ||
|---|---|---|---|---|
| Ethinyl estradiol | Placebo | 937.4 ± 265.8 | 105.6 ± 33.2 | 1.5 (1.0–3.0) |
| Silexan | 911.7 ± 263.3 | 106.6 ± 38.3 | 1.5 (0.9–3.0) | |
| Ratio or difference 90 % CI | 0.97 (0.93–1.02) | 0.99 (0.92–1.07) | 0.11 (−0.15 to 0.37) | |
| Levonorgestrel | Placebo | 94.3 ± 34.6 | 8.0 ± 2.6 | 1.0 (0.5–1.6) |
| Silexan | 90.3 ± 37.7 | 7.7 ± 2.8 | 1.1 (1.0–3.0) | |
| Ratio or difference 90 % CI | 0.94 (0.89–1.00) | 0.96 (0.91–1.01) | 0.29 (0.05–0.53) |
a Mean ± SD, back-transformed CI for ratio between marginal (geometric) means from ANOVA model, Silexan/placebo
b Median (range), confidence interval for difference between marginal (arithmetic) means from ANOVA model, Silexan—placebo
ANOVA analysis of variation, AUCτ area under the concentration–time curve over a dosing interval of τ = 24 h, CI confidence interval, C max peak concentration, SD standard deviation, t max time to C max