Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.
Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
Dose micronized 640 mg
The dose is 800 mg
AMR Clinical - Columbus
Columbus, Ohio, United States
Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)
Measures the time between a visual stimulus and response, measured in milliseconds
Time frame: Baseline dose to four (4 ) hours post-dose
Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT)
measures the time between a visual stimulus and response, measured in milliseconds
Time frame: Baseline dose to approximately 4 hours post-dose
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