Table I.
Descriptive Statistical Analysis of the Pharmacokinetic Parameters for the Test and the Reference Formulations
| Parameter | Test formulation | Reference formulation | ||
|---|---|---|---|---|
| ±SD | CV (%) | ±SD | CV (%) | |
| AUC0–t (ngh/mL) | 140 ± 64.6 (40.5–271) | 46.2 | 145 ± 58.9 (64.7–265) | 40.6 |
| AUC0–∞ (ngh/mL) | 188 ± 103 (42.4–422) | 54.5 | 194 ± 95.8 (66.6–372) | 49.4 |
| C max (ng/mL) | 33.2 ± 9.17 (18.6–54.2) | 27.6 | 36.2 ± 6.95 (23.3–57.0) | 26.6 |
| T max (h) | 1.96 ± 0.820 (0.670–4.00) | 41.8 | 1.99 ± 1.18 (1.00–6.00) | 59.1 |
| K el (1/h) | 0.29 ± 0.17 (0.10–0.70) | 58.4 | 0.27 ± 0.18 (0.10–0.72) | 65.3 |
| T 1/2 (h) | 3.12 ± 1.49 (0.990–6.73) | 47.6 | 3.44 ± 1.66 (0.960–6.98) | 48.3 |
AUC the area under the serum concentration vs. time curve, C max the maximum serum concentration, T max the time of maximum concentration, K el the elimination rate constant, T 1/2 the half time of elimination, SD the standard deviation, CV the coefficient of variation