Healthy Volunteers Clinical Trial
Official title:
A Single-Dose, Single-Center, Randomized, Five Period Crossover Study Comparing Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed to assess the comparative bioavailability and food effect of deflazacort. A total of 45 subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a crossover fashion.
This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed
to assess the comparative bioavailability and food effect of deflazacort. A total of 45
subjects will be randomly assigned to 1 of 5 treatment sequences. Each dosing sequence will
be enrolled in parallel and will receive all 5 treatments in a crossover fashion.
Subjects will be screened within 28 days of the first dose of study drug. Subjects will check
into the clinical pharmacology unit (CPU) on the day prior to dosing (Day -1 for Period 1)
and will stay in-house through the 24 hour assessments in each study period. Safety
assessments will be performed at screening, check-in for each period, and at 24 hours after
each dose per the Schedule of Assessments .Additionally, a safety follow-up phone call will
be performed on Day 36 (± 2 days).
Subject participation is expected to last approximately 64 days, including a 28-day screening
period and a 36-day on study period (consisting of 5 treatment periods, washout periods
lasting 7 days, and the safety follow-up phone call).
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