Phase 1Completed
Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone
A Single Centre, Open Label, Randomised, Crossover Study in Dexamethasone-suppressed Healthy Adult Male Volunteers to Compare the Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone Tablets at a Single Dose of 10 mg and to Evaluate the Dose Proportionality of Infacort® at Doses of 0.5 mg, 2 mg, 5 mg and 10 mg
- Sponsor
- Neurocrine UK Limited (Industry)
- Enrolment
- 16 enrolled
- Conditions
- Healthy Subjects
- Interventions
- Infacort; Hydrocortisone
- Ages
- adults
- Registry
- NCT02777268
Full record on ClinicalTrials.gov
From the registry
This was a single centre, open-label, randomised, 5-way crossover study.
Primary outcomes
- Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone
- Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone
- Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone
History
Last registry update
Results first posted
Registered
Primary completion
Started