Healthy Volunteers Clinical Trial
Official title:
An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects
This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects
This is a randomized, open label, single dose, parallel group study consisting of 3 groups
of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments
until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected
for 480 hours after dosing.
This study will compare the relative bioavailability of the oral DSM265 50% spray dried
dispersion (SDD) granules with that of a reference 25% SDD powder for suspension
formulation, and evaluate the effect of food on the DSM265 50% SDD granules
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label
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