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An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

NCT03019614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-12

No results posted yet for this study

Summary

This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).

Conditions

Interventions

DRUG

Hydrocortisone

Generic hydrocortisone

DRUG

Chronocort

Modified formulation of hydrocortisone

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • Salvatore Febbraro · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

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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 NCT03019614 on ClinicalTrials.gov