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Bioequivalence Study of Prednisolone and Dexamethasone

NCT04733144 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-12

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Prednisolone

7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)

DRUG

Dexamethasone

1,125 mg dexamethasone 4,5 mg dexamethasone

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • André P. van Beek, MD,PhD · University Medical Center Groningen

  • Stephan J.L. Bakker, MD,PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733144 on ClinicalTrials.gov