EUCTR2019-004983-23-NL进行中（未招募）1 期
Bioequivalence study of prednisolone and dexamethasone: corticosteroids revisited - CORE study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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