|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
24 October 2016 |
|
Main ID: |
NCT02608606 |
|
Date of registration:
|
03/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors
FKosl |
|
Scientific title:
|
Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02608606 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Chile
| | | | | | | |
|
Contacts
|
|
Name:
|
Carlos Benitez, Hepatologist |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pontificia Universidad Catolica de Chile |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Outline of immunosuppression that includes tacrolimus dosing every 12 hours.
- Stable plasma levels of tacrolimus in 3 consecutive measurements.
- Stable blood tests: biochemical profile, creatinine and liver profile.
- Absence of treatment with drugs that have interaction with tacrolimus (antifungal and
diltiazem) and use of grapefruit juice.
- Absence of active bacterial or viral infection and rejection episodes within 8 weeks
prior.
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Evidence of Liver Transplantation
|
|
Effects of Immunosuppressant Therapy
|
|
Intervention(s)
|
|
Drug: Tacrolimus
|
|
Primary Outcome(s)
|
|
Compare tacrolimus exposure using per oral and sublingual administration employing AUC (Area Under the Curve).
[Time Frame: 30 days]
|
|
Secondary Outcome(s)
|
|
Compare tacrolimus dose necessary to obtain similar trough levels employing per oral and sublingual administration
[Time Frame: 30 days]
|
|
Secondary ID(s)
|
|
FKoral-sl
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|