Status:
UNKNOWN
Bioequivalence Study of Prednisolone and Dexamethasone
Lead Sponsor:
University Medical Center Groningen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.
Detailed Description
Study design: A randomised, double blind, cross-over clinical trial. Study population: healthy human adult volunteers including 12 males and 12 females aged 18-75 years old. Intervention: In random ...
Eligibility Criteria
Inclusion
- Participants must be healthy with no relevant medical history and no use of medication.
- Female participants aged \<50 years must be using oral contraceptives and female participants age ≥50 years must be in the postmenopausal state
- Command of the Dutch language
- Providing written IC
- BMI between 18.5 and 30 kg/m2
- Participants must be between 18 and 75 years of age
Exclusion
- Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
- Potential participants with a medical history of:
- Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
- Diseases affecting the HPG-axis: e.g. Cushing disease.
- Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
- Psychiatric diseases
- Diabetes
- Shift workers
- Potential participants with a kidney function \<60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
- Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04733144
Start Date
March 4 2021
End Date
May 31 2022
Last Update
April 12 2022
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ