Pharmacokinetic study of rectal and sublingual administration of tacrolimus in healthy volunteers
- Conditions
- TransplantatieorgandonationTransplant
- Registration Number
- NL-OMON36191
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
healthy male and female volunteers;
18-65 years old;
using adequate contraception (female volunteers of childbearing potential);
able to comply with the study protocol;
willing to give written informed consent.
concomitant use of medication, grapefruit juice or St John*s worth;
smoking 10 or more cigarettes per day and not able or willing to retain from smoking on days of administration;
simultaneous participation in another clinical trial;
pregnancy or lactation (female volunteers);
abnormal liver biochemistry (>2x upper normal limit);
renal insufficiency (estimated creatinin clearance according to Cockroft-Gault < 70 mL/min);
blood pressure >160/100 mmHg, measured after at least 10 minurtes rest in semi-recumbant position;
prolonged QT interval, corrected for heart rate using the Bazett's formula;
active infection, as determined by clinical examination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Area under the blood concentration of tacrolimus - time curve (AUC).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Relative bioavailability (F), time point after administration at which maximal<br /><br>blood concentration of tacrolimus is reached (tmax) and elimination rate<br /><br>constant (kel). </p><br>