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Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration

NCT03178214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-11-09

No results posted yet for this study

Summary

This is a single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and yoghurt compared with direct administration to the back of the tongue in dexamethasone-suppressed healthy adult male subjects.

The study will comprise of a pre-study screen, followed by 3 treatment periods and a post-study follow-up.

Conditions

Interventions

DRUG

Infacort

Immediate-release multiparticulate formulation of hydrocortisone.

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • EMAS Pharma

    collaborator INDUSTRY

  • Voet Consulting

    collaborator INDUSTRY

  • Brush Clinical Research Ltd.

    collaborator INDUSTRY

  • Medical Matters International Ltd

    collaborator INDUSTRY

  • Neurocrine UK Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-07-26
Completion
2017-07-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03178214 on ClinicalTrials.gov