First administration to man of Org 25435, an intravenous anaesthetic: A Phase 1 Clinical Trial

BMC Anesthesiology

Table 3 Org 25435 pharmacokinetic parameter estimates. The model is based on 18 short (1 minute) infusions and 7 Target Controlled Infusions (30 minutes)

Parameter	Typical Value	95% Confidence Interval	CV%
CL mL kg^-1 min^-1	8.31	7.23-9.39	31.3
Q2 mL kg^-1 min^-1	13.7	-18.2* -45.6
Q3 mL kg^-1 min^-1	62.8	30.3-95.3	61.4
Q4 mL kg^-1 min^-1	12.4	7.47-17.3	35.4
V1 mL kg^-1 min^-1	38.7	18.9 - 58.5
V2 mL kg^-1 min^-1	56.2	-65.8* - 178
V3 mL kg^-1 min^-1	642	393 - 891	68.5
V4 mL kg^-1 min^-1	1380	1137 - 1624	8.5
Residual variability %	20.3	13.9 - 25.1

Confidence intervals were calculated as the typical parameter estimate ± 1.96 x standard error of the estimate. The coefficient of variation (CV%) was calculated as the square root of the variance of the eta variable associated with that parameter. CL = irreversible systemic clearance from the central compartment; Q2 = distribution clearance for the rapidly equilibrating peripheral compartment; Q3 = distribution clearance for the slower equilibrating peripheral compartment; Q4 = distribution clearance for the slowest equilibrating peripheral compartment; V1= volume of the central compartment; V2 = volume of the rapid peripheral compartment; V3 = volume of the slower peripheral compartment; V4 = volume of the slowest peripheral compartment. * These confidence intervals are symmetric approximations, the true confidence interval does not contain zero.

ISSN: 1471-2253