Transplantatie organdonation Transplant
Conditions
Interventions
Three single doses of tacrolimus will be administered in randomized order with
an interval of at least 1 week: I. subligual dose of 3 mg tacrolimus as a
powder obtained from commercially available c
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration of tacrolimus - time curve (AUC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative bioavailability (F), time point after administration at which maximal blood concentration of tacrolimus is reached (tmax) and elimination rate constant (kel). | — |
Countries
Netherlands
Outcome results
None listed