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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: safety [ Time Frame: 3 days ]
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