NCT03019614

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

An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

• Congenital Adrenal Hyperplasia
• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Hydrocortisone	Generic hydrocortisone
DRUG	Chronocort	Modified formulation of hydrocortisone

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2017-01-12
• Last updated: 2017-01-12