Table 1.
Summary of pharmacokinetic parameters of prolonged-release tacrolimus administered as a suspension orally and via nasogastric tube compared with oral administration of intact capsules
| Mode of prolonged-release tacrolimus administration (10 mg)* |
Ratio of least-squares means (90% CI) |
||||
|---|---|---|---|---|---|
| Intact capsule (oral) (n=20) | Suspension (oral) (n=20) | Suspension (nasogastric tube) (n=20) | Suspension (oral)— intact capsule |
Suspension (nasogastric tube)—intact capsule | |
| AUC0–∞ (ng.h/mL) | 334 (28.0) | 350 (29.6) | 277 (31.4) | 1.05 (0.96 to 1.14) | 0.83 (0.76 to 0.92) |
| AUC0–tz (ng.h/mL) | 318 (27.0) | 333 (29.4) | 263 (31.1) | 1.05 (0.96 to 1.14) | 0.83 (0.76 to 0.92) |
| Cmax (ng/mL) | 15.7 (28.4) | 20.4 (31.3) | 20.9 (22.6) | 1.30 (1.16 to 1.45) | 1.28 (1.13 to 1.45) |
| Tmax (h)† | 2.0 (1.0–3.0) | 1.0 (0.5–1.0) | 0.5 (0.5–1.0) | −1.0 (−1.25 to −0.75) | −1.5 (−1.50 to −0.75) |
| T½ (h) | 33.2 (13.4) | 33.2 (14.6) | 34.0 (12.2) | 1.00 (0.97 to 1.03) | 1.01 (0.98 to 1.05) |
All tests were two-sided and used the 5% level of significance.
*Geometric mean (CV%) are presented.
†Tmax is presented as median (range).
AUC0–∞, area under the concentration–time curve from time 0 to infinity post-tacrolimus dose; AUC0–tz, AUC measured up to the last quantifiable concentration of tacrolimus; Cmax, maximum observed concentration; CV, coefficient of variation; Tmax, time to maximum concentration; T½, elimination half-life of tacrolimus.