At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Infacort +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Infacort and Hydrocortisone for Healthy Subjects. Completed, enrolled 16 participants.
Detailed Summary
This was a single centre, open-label, randomised, 5-way crossover study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
CollaboratorsSimbec Research
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
Primary CompletionSep 2013
First PostedMay 2016
TodayJul 2026
First PostedMay 19, 2016
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago
Interventions
Infacortdrug
Multi-particulate granules
Hydrocortisonedrug
Tablet