Bioequivalence study of prednisolone and dexamethasone: corticosteroids revisited - CORE study

niversity Medical Center Groningen0 个研究点目标入组 24 人开始时间: 2020年9月1日最近更新: 2021年4月5日

试验速览

暂无简介。

•1.Participants must be healthy with no relevant medical history and no use of medication.
•2.Female participants must be using oral contraceptives
•3.Command of the Dutch language
•4.Providing written IC
•5.BMI between 18.5 and 30 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
•2.Potential participants with a medical history of:
•a.Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
•b.Diseases affecting the HPG-axis: e.g. diabetes
•c.Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
•d.Psychiatric diseases
•3.Shift workers.
•4.Potential participants with a kidney function <60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
•5.Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
•6.Potential participants who utilize any medication which is likely to confound assessment of the endpoint (e.g. inhaled corticosteroids, hormone supplements, psychotropic drugs, carbamazepine or vaccination)
•7.Potential participants who have known contraindication to the study medication (e.g. known peptic ulcer disease or active infectious disease)
•8.Potential participants who intend to undergo significant lifestyle changes e.g. voluntary weight loss and discontinue smoking habits.

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