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COMPLETED
NCT07622433
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Laroprovstat/ezetimibe FCDP

Laroprovstat/ezetimibe will be administered orally.

DRUG

Laroprovstat STP

Laroprovstat will be administered orally.

DRUG

Ezetimibe STP

Ezetimibe will be administered orally.

DRUG

Laroprovstat/ezetimibe FCDP-slow variant

Laroprovstat/ezetimibe slow variant will be administered orally

Locations (1)

Research Site

Brooklyn, Maryland, United States