|- candidate number||6775|
|- NTR Number||NTR2129|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-dec-2009|
|- Secondary IDs||NL28612.078.09 2009-013401-34|
|- Public Title||Correlation between prednisolone in saliva and (unbound) prednisolone in blood in healthy adults.|
|- Scientific Title||Correlation between prednisolone in saliva and (unbound) prednisolone in blood in healthy adults.|
|- hypothesis||Prednisolone concentrations in saliva reflect free prednisolone concentrations in blood.|
|- Healt Condition(s) or Problem(s) studied||Healthy subjects|
|- Inclusion criteria||Age 18-65 yrs.
|- Exclusion criteria||Use of medication that can influence pharmacokinetics of prednisolone:|
1. Hormonal contraceptives;
Conditons that can infuence pharmacokitetics of prednisolone:
2. Liver of renal dysfunction;
3. Renal transplantation
5. Crohn's disease;
6. Cushing's disease or syndrome;
7. Chronic lesions of the oral mucosa or tongue.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||2-dec-2009|
|- planned closingdate||1-jan-2010|
|- Target number of participants||20|
|- Interventions||A periferal venous catheter is positioned in the forearm followed by collection of baseline blood and saliva samples.
Subjects receive one oral dosis of 80 mg prednisolone. Blood and saliva samples are collected 1, 2, 3, 4, 5 and 6 ours after ingestion of prednisolone.|
|- Primary outcome||[Prednisolone] in saliva/[free prednisolone] in blood in time.|
|- Secondary outcome||Levels of corticosteroid binding globunline (CBG) and albumin in blood.|
|- Timepoints||1. Prior to ingestion of prednisolone;|
2. (Baseline), 1, 2 , 3, 4, 5 and 6 ours after ingestion.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Background of the study:|
Prednisolone is frequently prescribed in immune-mediated diseases. The therapeutic effect and side effects show interindividual variability, which can partly be explained by differences in pharmacokinetics between individuals. Measurement of prednisolone in saliva might serve as a patient friendly method in to indicate individual pharmacokinetics.
The chemical structure of prednisolone is virtually identical to that of cortisol. Both cortisol and prednisolone are largely bound to plasma proteins in blood. Only the free (unbound) fractions are biologically active. It has been established that only free cortisol can pass from blood to saliva and that salivary cortisol concentrations are very well correlated with the free concentration of cortisol in blood. Since prednisolone shows great resemblance to cortisol, a similar correlation would be expected. However, literature on this correlation for prednisolone is limited and controversial.
Establishing the clincal value of the measurement of prednisolone in saliva as an indicator of individual pharmacokinetics may contribute to te possibility of tailored treatment. In this pilot study, we aim to further investigate this clinical value by assessing the correlation between concentrations of prednisolone in blood and saliva in healty adult volunteers.
Objective of the study:
The aim of this study is to assess the correlation between concentrations of prednisolone in blood and saliva in healty adult volunteers and to establish the clinical value of the measurement of prednisolone in saliva as an indicator of individual pharmacokinetics of prednsolone.
Pharmacokinetic observational; healthy volunteers.
To assess the correlation between concentrations of prednisolone in blood and saliva we will recruit 20 healthy adult volunteers. Healthy adult men and women aged 18-65 years will be recruited.
Use of medication or conditions that can influence pharmacokinetics of prednisolone will exclude persons from participating.
Primary study parameters/outcome of the study:
Prednisolone concentrations (nmol/L):
1. Serum (total);
2. Serum (unbound/free);
Before ingestion of 80 mg prednisolone and 1, 2, 3, 4, 5 and 6 hours after ingestion.
Secundary study parameters/outcome of the study:
Serum albumine level (g/L), serum corticosteroid binding globulin (CBG) level (mg/L).
|- Main changes (audit trail)|
|- RECORD||2-dec-2009 - 11-dec-2009|