Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bioequivalence Study
研究概览
简要总结
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
- •age ≥ 18 years,
- •Patient´s written informed consent,
- •Ability to comply with the protocol procedures
- •Exclusion criteria
- •Diabetes mellitus,
- •Infectious disease with fever at time of investigation,
- •Known intolerance to the study drug or constituents oft he study drug,
- •Oral contraception,
- •Known pregnancy or breast feeding,
- •Renal failure (creatinine > 2.5 ULN)
排除标准
- 未提供
研究组 & 干预措施
Hydrocortisone subcutaneously first
Hydrocortisone subcutaneously first
干预措施: Hydrocortisone subcutaneously first (Drug)
Hydrocortisone intramuscular first
Hydrocortisone intramuscular first
干预措施: Hydrocortisone intramuscular first (Drug)
结局指标
主要结局
Bioequivalence Study
时间窗: 4 hours
pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)
次要结局
- safety(3 days)
研究者
Bruno Allolio
MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg
University of Wuerzburg
