At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers.
In Brief
A Phase 1 clinical trial evaluating Hydrocortisone granules, Hydrocortisone Tablet, and 2 other interventions for Adrenal Insufficiency. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection. The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.
Study Details
Timeline
Interventions
Multi-particulate granules
Standard hydrocortisone tablets
Standard hydrocortisone solution for intravenous injection
Challenge agent