Table 4.
Ratio of means (Sandoz MPH OCR/Concerta®) and 90% confidence intervals based on least-squares means from the ANOVA of the ln-transformed data from the fasting studies.
| Parameter (units) All mean ± SD | 54-mg fasting (n = 24) |
36-mg fasting (n = 22) |
18-mg fasting (n = 24) |
|||
|---|---|---|---|---|---|---|
| Ratio | 90% geometric CI | Ratio | 90% geometric CI | Ratio | 90% geometric CI | |
| AUC0–t | 95.95% | 92.68–99.33% | 93.45% | 90.27–96.73% | 95.83% | 92.99–98.76% |
| AUC0–inf | 97.12% | 94.12–100.21% | 94.91% | 91.51–98.44% | 96.35% | 93.64–99.13% |
| Cmax | 90.96% | 84.94–97.40% | 93.69% | 87.31–100.54% | 96.08% | 89.24–103.44% |
| AUC0–2h | 100.29% | 90.83–110.73% | 99.29% | 88.82–110.99% | 100.30% | 91.15–110.36% |
| AUC2–24h | 95.67% | 92.44–99.01% | 93.03% | 89.85–96.32% | 95.58% | 92.81–98.44% |
| Cmax(0–2h) | 97.88% | 90.95–105.33% | 95.11% | 86.36–104.74% | 101.99% | 94.28–110.33% |
| Cmax(2–24h) | 90.96% | 84.94–97.40% | 93.69% | 87.31–100.54% | 96.08% | 89.04–103.44% |
Ratios calculated using least-squares means according to the formula: e(treatment A (test) − treatment B (reference)) × 100. 90% geometric confidence interval uses ln-transformed data.