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Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only

NCT02408068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-05-04

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Dexamethasone

Dexamethasone used to suppress endogenous cortisol secretion

DRUG

Chronocort: fasted

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

DRUG

Immediate release hydrocortisone: fasted

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

DRUG

Chronocort: fed

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

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Neurocrine UK Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408068 on ClinicalTrials.gov