At a glance
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A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Abemaciclib Capsules (Reference Formulation) and Abemaciclib Tablet (Test Formulation) for Healthy. Completed, enrolled 127 participants across 2 sites.
Detailed Summary
The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected. This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part. This study is for research purposes only and is not intended to treat any medical condition.
Study Details
Timeline
Interventions
Administered orally
Administered orally