Bioequivalence study of prednisolone and dexamethasone; corticosteriods revised
- Conditions
- HPA as / stress hormone system10001353
- Registration Number
- NL-OMON50073
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
1. Participants must be healthy with no relevant medical history 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. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia
rheumatic, and chronic obstructive pulmonary disease
b. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal
insufficiency, pituitary tumors, and nightshift workers
c. Diseases affecting the HPG-axis: e.g. hemochromatosis, sarcoidosis, and
diabetes
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the bioequivalence of prednisolone and dexamethasone at a lower<br /><br>and a higher dose, as evaluated by the HPA axis, measured by cortisol in 24h<br /><br>urine </p><br>
- Secondary Outcome Measures
Name Time Method