CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Dexamethasone +3 moredrug
Likely dose
Chronocort: fasted 20mgfrom 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.

Search/NCT02408068
NCT02408068Phase 1Completed
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Open Label Randomised 3 Period Crossover Study to Evaluate Bioavailability of Modified Release Hydrocortisone (HC) Under Fasting & Fed Conditions & Immediate Release HC Tablets Under Fasting Conditions in Dexamethasone-suppressed Subjects

Neurocrine UK Limited·interventional·Posted Apr 3, 2015·Updated May 4, 2022

In Brief

A Phase 1 clinical trial evaluating Dexamethasone, Chronocort: fasted, and 2 other interventions for Healthy. Completed, enrolled 18 participants.

Detailed Summary

The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted). This information will be used to help doctors with dosing in clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
CollaboratorsSimbec Research

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartJan 1, 2015
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.2 years ago

Interventions

Dexamethasonedrug

Dexamethasone used to suppress endogenous cortisol secretion

Chronocort: fasteddrug

single dose of 20mg modified release hydrocortisone in the absence of food

Immediate release hydrocortisone: fasteddrug

single dose of 20mg immediate release hydrocortisone in the absence of food

Chronocort: feddrug

single dose of 20mg modified release hydrocortisone in the presence of food