A chronopharmacological study into the pharmacokinetics of midazolam

Completed

• Conditions: VT; stof wordt gebruikt als modelgeneesmiddel; NA

• Registration Number: NL-OMON33133
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

healthy
male
18-50 yrs

Exclusion Criteria

any clinically relevant medical condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>By analyzing the pharmacokinetic profiles of midazolam and sorbitol (used to<br /><br>estimate liver blood flow) for each administration the following parameters of<br /><br>midazolam will be determined:<br /><br>- CLint (intrinsic clearance)<br /><br>- CLsys (systemic clearance)<br /><br>- Cmax and Tmax (maximal concentration and time to reach this)<br /><br>- Volume of distribution<br /><br>- ERgut/ERliver: gastrointestinal/hepatic extraction ratio<br /><br>Circadian profiles will be determined for each parameter and per individual</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 24hour profile of TSH plasma concentrations as a marker for circadian phase<br /><br>of the subject.</p><br>