Bioequivalence study of prednisolone and dexamethasone – The CORE study
- Conditions
- .A.
- Registration Number
- NL-OMON24470
- Lead Sponsor
- .A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
1.Participants must be healthy with no relevant medical history (e.g. astma, solid organ transplantation, secondary adrenal insufficiency) and no use of medication.
2.Female participants aged <50 years must be using oral contraceptives and female participants age =50 years must be in the postmenopausal state
3.Command of the Dutch language
4.Providing written IC
5.BMI between 18.5 and 30 kg/m2
6. Participants must be between 18 and 75 years of age
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. Cushing disease.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is the difference in total cortisol excretion as measured in 24h-urine at between the lower doses of prednisolone and dexamethasone as well as between and the higher doses of prednisolone and dexamethasone doses.
- Secondary Outcome Measures
Name Time Method