Species | Route/Dose | Collection Interval | Percentage of Dose Recovered | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Urine | Bile | Feces | Cage Debris/Wash | Total | |||||||
h | mean ± S.D. | mean ± S.D. | mean ± S.D. | mean ± S.D. | mean ± S.D. | ||||||
Intact Rat (n = 3) | p.o. 15 mg/kg | 0–168 | 6.45 ± 0.82 | N.A. | 76.39 ± 8.45 | 6.70 ± 4.88 | 89.54 ± 4.73 | ||||
BDC Rata (n = 2) | p.o. 10 mg/kg | 0–12 | 3.2 (2.7, 3.6) | 35.8 (32.5, 39.1) | N.C. | N.C. | 39.0b (35.2, 42.7) | ||||
BDC Rata (n = 2) | i.v. 10 mg/kg | 0–12 | 12.0 (14.9, 9.1) | 67.4 (61.2, 73.6) | N.C. | N.C. | 79.4 (76.1, 82.7) | ||||
Intact monkey (n = 3) | p.o. 10 mg/kg | 0–168 | 2.99 ± 1.55 | N.A. | 76.82 ± 9.75 | 8.84 ± 8.62 | 88.65 ± 2.42 | ||||
BDC monkey (n = 3) | i.v. 2 mg/kg | 0–72 | 9.89 ± 2.88 | 67.24 ± 16.40 | 13.67 ± 12.66 | N.C. | 90.80 ± 2.56 |
N.A., not applicable; N.C., not collected
↵ a The BDC rat study was not run as a comprehensive mass-balance study; samples were only collected over a 12-h period. Because there were only two animals per treatment group, the S.D. was not reported. The mean and individual recoveries for each animal were reported
↵ b An additional 61.2 (Rat 1) and 44.7% (Rat 2) of the radioactive dose was recovered in the GI tract of p.o.-dosed animals at the end of the study (12 h after drug administration), bringing the mean total recovery of radioactivity to 92.0%