Pharmacokinetics of levetiracetam after rectal administration in healthy volunteers
- Conditions
- epilepsia10029305
- Registration Number
- NL-OMON30934
- Lead Sponsor
- Atrium Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
healthy volunteers
18-55 years
conformed consent
Exclusion Criteria
patients with epilepsia
pregnant women
breast feeding women
bad renal function
bad liver function
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Area-under- the-curve (AUC)<br /><br>- Relative bioavailability (Frel= AUCrectal/AUCoral)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Maximum concentation (Cmax)<br /><br>- Time to maximum concentration (Tmax)<br /><br>- Clearance (Cl)<br /><br>- Volume of distribution (Vd)<br /><br>- Elimination constant (Kel)<br /><br>- Elimination half-life(T1/2)</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms and drug targets are involved in levetiracetam's rectal absorption and antiepileptic efficacy?
How does rectal levetiracetam compare to oral or intravenous administration in terms of pharmacokinetics and seizure control for epilepsy?
Which biomarkers predict optimal rectal levetiracetam absorption and therapeutic response in epilepsy patients?
What are the known or potential adverse events associated with rectal levetiracetam and their management strategies in clinical settings?
Are there alternative antiepileptic drugs with rectal formulations that demonstrate similar pharmacokinetic profiles to levetiracetam?