Table 1.
Bioequivalence assessment and statistical analysis of azimilide pharmacokinetic parameters in the fed (high-fat meal) and fasted states.a
| Least square geometric means | ||||
|---|---|---|---|---|
| Parameter | Fed state | Fasted stated | Point estimate of ratio: fed to fasted (%) | 90% confidence interval of ratio (%) |
| AUCtlast (ng ml−1 h) | 4825 | 5086 | 94.9 | 88.8, 101.3 |
| AUC(0,∞) (ng ml−1 h) | 5578 | 5796 | 96.2 | 90.5, 102.4 |
| Cmax (ng ml−1) | 63.7 | 78.3 | 81.4 | 76.2, 87.0 |
| Least square means | ||||
|---|---|---|---|---|
| Fed state | Fasted state | Point estimate of ratio: fed to fasted (%) | 95% confidence interval: ratio of fed to fasted (%) (P value) | |
| Geometric means | ||||
| tmax (h) | 6.84 | 6.29 | 108.8 | 92.1, 123.2 (P = 0.1764) |
| Arithmetric means | Difference of test – reference | |||
| t½,Z (h) | 89.1 | 79.9 | 9.25 | −0.5, 19.0 (P = 0.0626) |
a
AUCtlast = area under the blood concentration-time curve from time zero to the last quantifiable concentration; AUC(0,∞) = area under the blood concentration-time curve from time zero to infinity; Cmax = maximum blood concentration; tmax = time at which the maximum blood concentration occurs; and t½,Z = terminal exponential half-life