Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733144
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2021-01-15
Brief Title:
Bioequivalence Study of Prednisolone and Dexamethasone
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
An Bioequivalence Study of Prednisolone and Dexamethasone Corticosteroids Revised - The CORE Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORE
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 order subjects will receive 75 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 1125 mg dexamethasone for one week directly followed by 45 mg dexamethasone for one week
Main study parametersendpoints 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
Study population healthy human adult volunteers including 12 males and 12 females aged 18-75 years old
Intervention In random order subjects will receive 75 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 1125 mg dexamethasone for one week directly followed by 45 mg dexamethasone for one week
Main study parametersendpoints 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004983-23 | EUDRACT_NUMBER | None | None |