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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual - Rectal - Oral | Experimental | Administration order of rank: Sublingual - Rectal - Oral |
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| Sublingual - Oral - Rectal | Experimental | Administration order of rank: Sublingual - Oral - Rectal |
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| Oral - Sublingual - Rectal | Experimental | Administration order of rank: Oral - Sublingual - Rectal |
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| Oral - Rectal - Sublingual | Experimental | Administration order of rank: Oral - Rectal - Sublingual |
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| Rectal - Sublingual - Oral | Experimental | Administration order of rank: Rectal - Sublingual - Oral |
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| Rectal - Oral - Sublingual | Experimental | Administration order of rank: Rectal - Oral - Sublingual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve, bioavailability, time of maximal concentration, elimination constant | t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Afke van de Plas, Hospital Pharmacist | Contact | +31433874733 | a.vande.plas@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Johannes van Hooff, Professor | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Hospital | Recruiting | Maastricht | 6229 HX | Netherlands |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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