Organ Transplantation Clinical Trial
Official title:
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included. - Age: 18 - 65 years - Patient's informed consent Exclusion Criteria: - Patients that use drugs that interact with tacrolimus - Patients that participate in other studies - Patients that are treated with tacrolimus |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Hospital | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve, bioavailability, time of maximal concentration, elimination constant | t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours | No |
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