Table II.
In Vivo Pharmacokinetic (PK) Parameters Following Oral Administration of the Reference Product and Test Formulation in Healthy Male and Female Beagles
| Bioequivalence study (n = 8; 4 males and 4 females) | ||||||
|---|---|---|---|---|---|---|
| PK parameter | AUC0–t (ng · h/mL) | AUC0–∞ (ng · h/mL) | C max (ng/mL) | T max (h) | T 1/2 (h) | Kel (1/h) |
| Reference product | ||||||
| Mean | 53,516.01 | 57,741.37 | 2,383.70 | 5.17 | 23.15 | 0.043 |
| SD | 13,796.42 | 17,064.20 | 571.37 | 1.92 | 31.88 | 22.65 |
| Test formulation | ||||||
| Mean | 54,020.00 | 57,705.06 | 2,413.61 | 5.29 | 20.34 | 0.049 |
| SD | 14,389.63 | 21,858.65 | 626.60 | 2.44 | 45.27 | 36.41 |
AUC area under curve; C max peak concentration; T max peak time; T 1/2 half-life; Kel elimination rate constant; SD standard deviation