drugset / Trial / NCT03051893
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocortisone | Other / unclassified | 5 mg | — |
| Subject | Hydrocortisone | Other / unclassified | 10 mg | — |
| Subject | Hydrocortisone | Other / unclassified | 20 mg | — |
| Subject | Hydrocortisone | Other / unclassified | 30 mg | — |