Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors (FKosl)
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|ClinicalTrials.gov Identifier: NCT02608606|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Evidence of Liver Transplantation Effects of Immunosuppressant Therapy||Drug: Tacrolimus||Not Applicable|
The patient will be scheduled fasting to liver transplant unit where the pharmacokinetic study was performed. After installation of the venous needle, blood samples will be collected on 4 ml tubes with EDTA as an anticoagulant at the following intervals of time in hours: 0 (immediately before the oral administration of tacrolimus); 0.5; 1.0; 1.5; 2; 4; 6; 9 and 12 h. post-dose. Once the blood samples taken, the tubes will be plugged, invest gently to mix with anticoagulant and stored at -20 ° C until analysis.
Subsequently, tacrolimus administration was change to sublingual route and dose was adjusted to obtain similar trough levels to those determined on per oral administration. The capsule be opened and its contents shall be deposited in the sublingual mucosa. To be ensure that drug will be absorted the patient will be instructed to insistently that after sublingual placement of the drug, should not swallow the capsule content for at least 15 minutes. The same pharmacokinetic study described for the oral route will be performed.
Breakfast will be administered 2 hours after ingesting the drug and lunch and dinner 6 and 10 hours after respectively. Fluid intake is discretionary.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
No Intervention: oral administration of tacrolimus
Oral administration of tacrolimus (FK506) in the usal dose and measuring plasmatic levels at hours 0, 0.5, 1, 2, 3, 4 and 6. Measuring AUC.
Active Comparator: sublingual administration of tacrolimus
sublingual administration of tacrolimus (FK506) in the dose that allows similar plasmatic level at time 0 compared with the oral administration, and measuring plasmatic levels at hours 0, 0.5, 1 , 2, 3 , 4 and 6. Measuring AUC.
compared oral administration versus sublingual administration of tacrolimus.
Other Name: FK506
- Compare tacrolimus exposure using per oral and sublingual administration employing AUC (Area Under the Curve). [ Time Frame: 30 days ]compared oral administration versus sublingual administration of tacrolimus
- Compare tacrolimus dose necessary to obtain similar trough levels employing per oral and sublingual administration [ Time Frame: 30 days ]compared oral administration versus sublingual administration of tacrolimus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608606
|Pontificia Universidad Catolica de Chile|
|Santiago, Chile, 8330024|
|Principal Investigator:||Carlos Benitez, Hepatologist||Pontificia Universidad Catolica de Chile|