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EXCLUSIVE: Adial Pharmaceuticals Reveals Topline Results From Pharmacokinetics Study Of AD04 For Alcohol Use Disorder [Yahoo! Finance]
Last amgen inc. earnings: 4/30 04:01 pm
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US:NASDAQ Investor Relations: investors.amgen.com
This data will help the company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completing the study also satisfied an FDA requirement for the upcoming Phase 3 trials of AD04. Also Read: EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder The single-center, relative bioavailability, open-label study enrolled 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.3
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