Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT03311932
Brief Summary:
This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.
Detailed Description:
The study was conducted in two parts (Part 1 and 2) which were not performed sequentially. In Part 1, 26 subjects were dosed in a fasted condition and in Part 2, 25 subjects were dosed in a fed condition. Each part comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.
Screening assessments (for Parts 1 and 2) were conducted within the 28 days before the first administration of a study intervention. Eligible participants were asked to return for the 2 treatment periods. Continued eligibility was confirmed pre-dose for each treatment period.
Part 1 (fasted state): Treatment Periods: Eligible participants received a single dose of each study intervention over 2 treatment periods (1 per treatment period). Each treatment period was approximately 1.5 days in duration. Participants arrived at the Clinical Unit on Day -1 and dexamethasone 1 mg was administrated at approximately 22:00 hours and then again at approximately 06:00 and 12:00 of Day 0 of each treatment period to suppress endogenous cortisol production. The study intervention was administered at approximately 08:00 on Day 0 in the fasted state (after an overnight fast of at least 10 hours). Participants were discharged following the 12-hour post-dose blood sampling and consumption of a snack (Day 0).
Part 2 (fed state): The same procedures were followed as for Part 1 except that study interventions were administered in a fed condition (30 minutes after the start of a standardised high-fat breakfast). PK samples in both study parts were collected pre-dose and up to 12 hours post-dose (19 samples for each treatment period) for measurement of cortisol levels. Safety was evaluated throughout the study. There was at least a 7-day washout period (up to a maximum of 14 days) between dose administrations. After completion of both study periods, participants were to return 7±2 days later for a final follow-up visit.
Study:
NCT03311932
Study Brief:
Protocol Section:
NCT03311932