NCT04733144

Bioequivalence Study of Prednisolone and Dexamethasone

An Bioequivalence Study of Prednisolone and Dexamethasone; Corticosteroids Revised - The CORE Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 order, subjects will receive 7,5 mg prednisolone for one week, directly followed by 30 mg of prednisolone for one week. After a washout period of 4 weeks (or by exception 8 weeks), subjects will receive 1,125 mg dexamethasone for one week, directly followed by 4,5 mg dexamethasone for one week. Main study parameters/endpoints: The main study endpoint is the difference in total urinary cortisol excretion as measured in 24h-urine between the lower doses of prednisolone and dexamethasone as well as between the higher doses of prednisolone and dexamethasone.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Prednisolone	7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)
DRUG	Dexamethasone	1,125 mg dexamethasone 4,5 mg dexamethasone

Timeline

• Start date: 2021-03-04
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-02-01
• Last updated: 2022-04-12

Locations

1 site across 1 country: Netherlands