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A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects

NCT03343327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-06-19

No results posted yet for this study

Summary

This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.

Conditions

Interventions

DRUG

Chronocort®

Single dose of 20mg Chronocort® administered in one treatment period

DRUG

Cortef®

Single dose of 20mg Cortef® administered in one treatment period

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Brush Clinical Research Ltd.

    collaborator INDUSTRY

  • Voet Consulting

    collaborator INDUSTRY

  • Bionical Emas Ltd.

    collaborator UNKNOWN

  • Medical Matters International Ltd

    collaborator INDUSTRY

  • 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
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-04-20
Completion
2018-04-20
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 NCT03343327 on ClinicalTrials.gov