This study does not investigate a medical condition and is performed in healthy volunteers.
Conditions
Interventions
Trade Name: Prednisolone
Product Name: Prednisolone
Pharmaceutical Form: Capsule
Trade Name: Prednisolone
Product Name: Prednisolone
Pharmaceutical Form: Capsule
Trade Name: Dexamethasone
Product Na
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters will be: - Suppression of the HPA-axis measured by plasma cortisol, adrenocorticotropic hormone, and metabolites in the steroid profile in 24h urine (e.g. free and total cortisol, tetrahydrocortisol, tetrahydrocortisone, and allo-tetrahydrocortisol). - Suppression of the HPG-axis measured by testosterone, LH, FSH, SHBG, dihydrotestosterone, and steroid profile in 24h urine (e.g. androsterone, etiocholanolone, and dehydroepiandrosterone). - The pharmacokinetics and pharmacodynamics of prednisolone and dexamethasone. - Suppression of the immune system measured by leucocyte count, granulocyte count (neutrophils, eosinophil’s, and basophils), monocyte count, absolute B cell (CD19+) count, absolute T cell (CD3+, CD4+ and CD8+) count, absolute natural killer cell (CD16+ en CD56+) count, and RNA. - Renin–angiotensin–aldosterone system measured by plasma renin, aldosterone, potassium, 24h urine potassium, and trans-tubular potassium gradient. - Muscle mass measured by 24h urinary creatinine excretion rate and creatine kinase. - Metabolic parameters measured by fasting glucose, fasting insulin, HbA1c, cholesterol, triglycerides, glycerol, and non-esterified fatty acids. - Bone status as measured by calcium and osteocalcin - Clinical parameters: body weight, height, waist circumference, hip circumference, blood pressure - Neurocognitive function as measured by CanTab Cognitive and Psychological test ;Timepoint(s) of evaluation of this end point: All study visits ( 5 times) | — |
Countries
Netherlands
Contacts
Public ContactSuzanne P. Stam
University Medical Center Groningen
Outcome results
None listed