Table 2.
Pharmacokinetics of fexofenadine (120 mg) in 18 healthy volunteers after administration with 240 ml of water, grapefruit juice (GFJ), or modified GFJ (mGFJ)
| Outcome | Geometric Mean (CV%) | Geometric Mean Ratio (90% CI) | |||
|---|---|---|---|---|---|
| Water | GFJ | mGFJ | GFJ/Water | GFJ/mGFJ | |
| AUC0-∞ (μmol/l ·h) | 4.22 (40.0) | 3.22a (33.5) | 3.15 (28.6) | 0.76 (0.3–1.4) | 0.98 (0.4–1.5) |
| Cl/F (l/h) | 52.8 (40.0) | 69.3b (33.5) | 70.9 (29.6) | 1.31 (0.70–1.92) | 1.02 (0.45–1.60) |
| Cmax (μmol/l) | 0.57 (52.2) | 0.45c (43.7) | 0.44 (32.4) | 0.78 (0.17–1.39) | 0.97 (0.35–1.60) |
| t½ (h) | 11.9 (36.5) | 10.3d (37.6) | 10.3 (29.7) | 0.86 (0.28–1.45) | 1.01 (0.43–1.58) |
| tmax (h) [median (range)] | 3 (1–6) | 3.5e (1.5–5) | 4 (2–6) | ||
AUC0-∞, area the curve from time zero to infinity; Cl/F, apparent oral clearance; Cmax, maximum concentration; t½, terminal half-life; tmax, time to Cmax
Statistical comparisons for all outcomes except tmax were made between water and GFJ and between GFJ and mGFJ using a one-tailed paired Student’s t-test with Bonferroni correction (p < 0.025).
a
p = 0.008
b
p = 0.023
c
p = 0.011
d
p = 0.11
e
p = 0.135 (Wilcoxon signed-rank test)