NL-OMON50073已完成不适用
Bioequivalence study of prednisolone and dexamethasone; corticosteriods revised - CORE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participants must be healthy with no relevant medical history and no use of
- •medication.
- •2. Female participants aged <50 years must be using oral contraceptives and
- •participants age >=50 years must be in the postmenopausal state
- •3. Command of the Dutch language
- •4. Providing written IC
- •5. BMI between 18.5 and 30 kg/m2
- •6. Participants must be between 18 and 75 years of age
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. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia
- •rheumatic, and chronic obstructive pulmonary disease
- •b. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal
- •insufficiency, pituitary tumors, and nightshift workers
- •c. Diseases affecting the HPG-axis: e.g. hemochromatosis, sarcoidosis, and
- •d. Psychiatric diseases
- •e. Diabetes
- •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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