NVT
Conditions
Interventions
Midazolam (2 mg) will be administered orally and 150 min later this will be
followed by an intravenous dose of 1 mg given over a 1 min period. Sorbitol (2
gram as a 1 min iv infusion) will be given
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy male 18-50 yrs
Exclusion criteria
Exclusion criteria: any clinically relevant medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| By analyzing the pharmacokinetic profiles of midazolam and sorbitol (used to estimate liver blood flow) for each administration the following parameters of midazolam will be determined: - CLint (intrinsic clearance) - CLsys (systemic clearance) - Cmax and Tmax (maximal concentration and time to reach this) - Volume of distribution - ERgut/ERliver: gastrointestinal/hepatic extraction ratio Circadian profiles will be determined for each parameter and per individual | — |
Secondary
| Measure | Time frame |
|---|---|
| - 24hour profile of TSH plasma concentrations as a marker for circadian phase of the subject. | — |
Countries
Netherlands
Outcome results
None listed