Medication comparison studie of prednisolone and dexamethasone

Phase 1

• Conditions: This study does not investigate a medical condition and is performed in healthy volunteers.; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2019-004983-23-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Participants must be healthy with no relevant medical history and no use of medication.
2.Female participants must be using oral contraceptives
3.Command of the Dutch language
4.Providing written IC
5.BMI between 18.5 and 30 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
2.Potential participants with a medical history of:
a.Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
b.Diseases affecting the HPG-axis: e.g. diabetes
c.Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
d.Psychiatric diseases
e.Diabetes

3.Shift workers.
4.Potential participants with a kidney function <60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
5.Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
6.Potential participants who utilize any medication which is likely to confound assessment of the endpoint (e.g. inhaled corticosteroids, hormone supplements, psychotropic drugs, carbamazepine or vaccination)
7.Potential participants who have known contraindication to the study medication (e.g. known peptic ulcer disease or active infectious disease)
8.Potential participants who intend to undergo significant lifestyle changes e.g. voluntary weight loss and discontinue smoking habits.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objectieve of the current clinical trial is to re-examine the bioequivalance of prednisolone and dexamethasone on multiple physiological components of the human body, including the hypothalamic-pituitary-adrenal axis (HPA-axis). ;Secondary Objective: - To compare and examine the effects of prednisolone and dexamethasone in a (double-blind) randomized clinical trial<br>- To study the (potential difference in) effects of prednisolone and dexamethasone using modern and more accurate laboratorytechniques.;Primary end point(s): The primary study parameter will be the bioequivalence of prednisolone and dexamethasone as determined by the level of suppression of total cortisol excretion in 24h-urine between low dose prednisolone and dexamethasone and high dose prednisolone and dexamethasone. ;Timepoint(s) of evaluation of this end point: All study visits ( 5 times)