Pharmacokinetic study of rectal and ublingual administration of tacrolimus in healthy volunteers.
- Conditions
- Tacrolimus, rectal, sublingual, pharmacokinetics.Tacrolimus, rectaal, sublinguaal, farmacokinetiek.
- Registration Number
- NL-OMON20457
- Lead Sponsor
- Dr. MHL ChristiaansMaastricht University Medical CentreP. Debyelaan 256229 HX Maastricht
- Brief Summary
van de Plas, A., et al., Pilotstudy naar farmacokinetiek bij sublinguale en rectale toediening van tacrolimus. Pharm Weekbl 2008. 2(3): p. 66-8.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Legally capacitated;
2. 18-65 years old;
Exclusion Criteria
1. Concomitant use of medication, grapefruit juice or St John’s worth;
2. Smoking 10 or more cigarettes per day;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the blood concentration of tacrolimus – time curve (AUC).
- Secondary Outcome Measures
Name Time Method Relative bioavailability (F) for rectal and sublingual administration compared to oral administration of tacrolimus, time point after administration at which maximal blood concentration of tacrolimus is reached (tmax) and elimination rate constant (kel) for tacrolimus.