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COMPLETED
NCT03178214
PHASE1

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

Sponsor: Neurocrine UK Limited

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2017-05-22

Completion Date

2017-07-26

Last Updated

2026-09-14

Healthy Volunteers

Yes

Interventions

DRUG

Infacort

Immediate-release multiparticulate formulation of hydrocortisone.

Locations (1)

Simbec Research Ltd.

Merthyr Tydfil, United Kingdom