Table 2.
Summary statistics for digoxin AUC0–24h, Cmax, Tmax and urinary excretion following a single dose of 0.25 mg oral digoxin in healthy volunteers (n = 14) receiving daily oral doses of etoricoxib 120 mg or placebo
Parameter Day 10 | Digoxin + Etoricoxib | Digoxin + Placebo | CV* | GMR Etoricoxib/placebo | 90% CI for GMR |
---|---|---|---|---|---|
AUC0–24h (ng h ml−1) | 13.3 ± 4.25‡ | 12.5 ± 2.38‡ | 13.6% | 1.06 | (0.97, 1.17) |
Cmax (ng ml−1) | 1.76 ± 0.52‡ | 1.32 ± 0.18‡ | 14.4% | 1.33 | (1.21, 1.46) |
Tmax (h) | 0.5 (0.5, 1.5)† | 1.0 (0.5, 1.5)† | |||
Urinary excretion (µg) | 119.5 ± 15.30‡ | 109.0 ± 16.90‡ | 13.1% | 1.10 | (1.00, 1.20) |
AUC, Area under the plasma concentration–time curve; Cmax, maximum concentration of drug observed in the plasma; Tmax, time to reach maximum concentration; GMR, geometric mean ratio; CI, confidence interval.
Coefficient of variation (CV) = 100 × root mean square error from the analysis of variance (anova) model (within-subject variation). Ranges were 0.59–1.26 for AUC, 1.00–2.18 for Cmax.
Median (min, max).
Geometric mean ± back-transformed SD. The SD was computed as follows: SQRT(EXP(STD**2)*(EXP(STD**2)−1))*(Back-Transformed Mean), where STD is the log-scale SD.