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A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects

NCT03311932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-10-29

No results posted yet for this study

Summary

This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.

Conditions

Interventions

DRUG

Infacort®

Immediate release multiparticulate formulation (granules) of hydrocortisone

DRUG

Cortef®

Immediate release hydrocortisone tablets

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Brush Clinical Research Ltd.

    collaborator INDUSTRY

  • Voet Consulting

    collaborator INDUSTRY

  • Bionical-Emas Pharma Ltd

    collaborator UNKNOWN

  • Medical Matters International Ltd

    collaborator INDUSTRY

  • Nichol Pharma Services Ltd.

    collaborator UNKNOWN

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • A Koch · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2018-07-13
Completion
2018-07-13
FDA Drug
Yes

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 NCT03311932 on ClinicalTrials.gov