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临床试验/NCT01450930
NCT01450930已完成2 期

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency

Bruno Allolio1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Hydrocortisone subcutaneously first

干预措施: Hydrocortisone subcutaneously first (Drug)

Hydrocortisone intramuscular first

Active Comparator

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

发起方
Bruno Allolio
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bruno Allolio

MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg

University of Wuerzburg

研究点 (1)

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