Table 2.
Point estimates and 90% confidence intervals for the comparison of pharmacokinetic parameters evaluated for Adalat® OROS and Slofedipine® XL after administration to fed and fasted healthy volunteers.
| Variable (unit) | Slofedipine® XL – Fasting vs Adalat® OROS – Fasting | Slofedipine® XL – Non-fasting vs Adalat® OROS – Non-fasting | Adalat® OROS – Non-fasting vs Adalat® OROS – Fasting | Slofedipine® XL – Non-fasting vs Slofedipine® XL – Fasting | |
|---|---|---|---|---|---|
| Cmax (µg l−1) | PE | 84.3 | 81.0 | 110.8 | 106.4 |
| 90% CI | 70.9, 100.2 | 65.8, 99.6a | 93.2, 131.7 | 89.5, 126.5 | |
| AUC(0,∞) (µg l−1 h) | PE | 82.3 | 69.6 | 116.4 | 98.4 |
| 90% CI | 65.8, 103.0 | 53.7, 90.2 | 93.0, 145.7 | 75.9, 127.7 | |
| AUC(0,tn)a (µg l−1 h) | PE | 84.7 | 71.2 | 119.2 | 100.1 |
| 95% CI | 66.0, 108.7 | 55.5, 91.3 | 92.9, 152.9 | 78.0, 128.4 | |
| AUC(0,24 h)a (µg l−1 h) | PE | 79.6 | 28.0 | 120.2 | 42.4 |
| 95% CI | 61.1, 103.7 | 21.5, 36.5 | 92.3, 156.7 | 32.5, 55.2 | |
| tmax (h)b | PE | 4.50 | 15.0 | 0.00 | 9.49 |
| 95% CI | 0.98, 8.51 | 10.5, 19.0 | −4.62, 5.50 | 4.98, 13.0 | |
| tlag (h)b | PE | 0.38 | 10.4 | 0.48 | 9.75 |
| 95% CI | 0.00, 0.56 | 8.29, 13.5 | 0.01, 0.75 | 8.50, 13.5 |
a
Note: =95% confidence intervals
b
=Non-parametric analysis; PE=Point Estimate; CI=Confidence Interval.