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A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults
Sponsor: AstraZeneca
Summary
The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.
Official title: A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-06-10
Completion Date
2026-09-06
Last Updated
2026-09-28
Healthy Volunteers
Yes
Conditions
Interventions
Laroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
Laroprovstat STP
Laroprovstat will be administered orally.
Ezetimibe STP
Ezetimibe will be administered orally.
Laroprovstat/ezetimibe FCDP-slow variant
Laroprovstat/ezetimibe slow variant will be administered orally
Locations (1)
Research Site
Brooklyn, Maryland, United States