Bioequivalence Study of Prednisolone and Dexamethasone

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Dexamethasone; Prednisolone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers

2. Diseases affecting the HPG-axis: e.g. Cushing disease.

3. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma

4. Psychiatric diseases

5. 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