Bioequivalence Study of Prednisolone and Dexamethasone
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 prednisol...
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.
Tracking Information
- NCT #
- NCT04733144
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: André P. van Beek, MD,PhD University Medical Center Groningen Principal Investigator: Stephan J.L. Bakker, MD,PhD University Medical Center Groningen
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