Clinical Trial: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Bruno Allolio

Current Primary Outcome: Bioequivalence Study [ Time Frame: 4 hours ]

pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)


Original Primary Outcome: Same as current

Current Secondary Outcome: safety [ Time Frame: 3 days ]

number of adverse events after subcutaneous administration of hydrocortisone


Original Secondary Outcome: Same as current

Information By: University of Wuerzburg

Dates:
Date Received: September 29, 2011
Date Started: November 2011
Date Completion:
Last Updated: July 31, 2012
Last Verified: July 2012