Table 5.
Oral | Mid-lactation | Post-partum | P-value |
---|---|---|---|
Cmax (μg/mL) | 1.45 (1.12–1.88) | 2.61 (1.79–3.67) | 0.02 |
Tmax (h) | 10.48 (8.50–12.83) | 16.75 (12.25–22.42) | 0.02 |
Vz/F (L/kg) | 0.39 (0.27–0.60) | 0.22 (0.17–0.33) | 0.02 |
CL/F (L/kg/h) | 0.03 (0.02–0.04) | 0.01 (0.007–0.019) | 0.008 |
AUC∞ (h x μg/mL) | 36.01 (24.29–51.02) | 82.82 (50.55–126.77) | 0.008 |
AUC%extrapolated | 0.60 (−0.09–1.89) | 0.47 (0.17–0.89) | 0.69 |
λz (h−1) | 0.07 (0.06–0.08) | 0.06 (0.05–0.07) | 0.05 |
AUMC∞ (h x μg/mL) | 733.95 (394.66–1194.39) | 2287.61 (981.54–4354.35) | 0.008 |
MRT∞ (h) | 20.38 (17.16–24.02) | 27.62 (21.56–34.90) | 0.05 |
T1/2 (h) | 9.55 (8.26–10.99) | 12.28 (9.60–15.42) | 0.05 |
F (%) | 87.2 | 101.6 | –* |
Results are presented in geometric means and range. P-values are based on non-parametric Wilcoxon Rank Sums 2-sample normal approximation.
Parameters include maximum plasma concentration (Cmax), time of Cmax (Tmax), area under the curve extrapolated to infinity (AUC∞), area under the curve percent extrapolated (AUC%extrapolated), area under the first momentum curve to infinity (AUMC∞), slope of terminal phase (λz), terminal half-life (T1/2), volume of distribution per fraction of drug absorbed (Vz/F), mean residence time (MRT∞), clearance per fraction of drug absorbed (CL/F), and absolute bioavailability (Fabs).
Statistical comparisons could not be made between treatment groups due individual animals receiving a single treatment and therefore clearance cannot be assumed to be consistent.