Study | Status of Patients | Dose Type | Dose Level | Subjects | Body Weight | Age | Male |
---|---|---|---|---|---|---|---|
mg/kg | n | kg | yr | % | |||
Doenicke et al. (1997) | Intact | Intravenous bolus | 2 | 12 | ND | 24–42a | 100 |
2 | 12 | ND | 24–42a | 100 | |||
Gepts et al. (1987) | Intact | Intravenous infusion over 2 h | 6 | 6 | 75.0 (7.2) | 60.3 (4.9) | 100 |
12 | 6 | 65.5 (7.9) | 50.6 (14.7) | 67 | |||
18 | 6 | 61.6 (8.8) | 39.8 (10.0) | 50 | |||
Veroli et al. (1992) | Anhepatic | Intravenous bolus | 0.5 | 10 | 60.0 (7.0) | 38.0 (ND) | ND |
ND, not detailed; PBPK, physiologically based pharmacokinetic.
↵a Mean age not detailed; age range of subjects presented instead