drugset / Trial / NCT03051893

A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations

NCT03051893

Phase 1 Completed 28 enrolled Neurocrine UK Limited Simbec Research · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This was an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers. The washout interval in both Part A and Part B was 1-week in between each treatment period.

Timeline

Start
2011-02
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 5 mg
Subject Hydrocortisone Other / unclassified 10 mg
Subject Hydrocortisone Other / unclassified 20 mg
Subject Hydrocortisone Other / unclassified 30 mg