Table 2.
Overview of pharmacokinetic outcome parameters
| Parameter | Oral | Rectal | Ratio rectal/oral (90% CI) | ||
|---|---|---|---|---|---|
| Geometric mean (90% CI) | CV% | Geometric mean (90% CI) | CV% | ||
| Tmax (h) | 1.58 (1.37–1.80) | 44.7 | 4.23 (3.35–5.10)* | 52.3 | 3.23 (2.28–4.17) |
| Cmax (μg l−1) | 34.5 (30.10–39.50) | 34.1 | 23.1 (19.8–26.9)* | 38.7 | 0.67 (0.57–0.79) |
| DnCmax (μg l−1 mg−1) | 4.9 (4.3–5.6) | 34.1 | 1.5 (1.3–1.8)* | 38.7 | 0.31 (0.27–0.37) |
| AUC0–24 (μg h l−1) | 194 (170–222) | 33.0 | 292 (233–365)* | 59.5 | 1.5 (1.22–1.85) |
| DnAUC0–48 (μg h l−1 mg−1) | 28 (24–32) | 33.0 | 19 (16–24)* | 59.5 | 0.70 (0.57–0.86) |
| AUC0–48 (μg h l−1) | – | – | 394 (309–504) | 65.2 | NA |
| DnAUC0–48 (μg h l−1 mg−1) | – | – | 26 (21–34) | 65.2 | NA |
| T1/2 (h) | 24.0 (19.5–28.5) | 36.85 | 22.8 (21.6–24.0) | 27.23 | NA |
Abbreviations are as follows: AUC, area under the blood concentration-time curve; CI, confidence interval; Cmax, maximal blood concentration; CV%, between-subject coefficient of variation; Dn, dose-normalized; NA, not applicable; Tmax, time to reach maximal concentration; T1/2, drug concentration half-life.
*
P < 0.05 for oral vs. rectal administration, anova.