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RECRUITING
NCT07316608
PHASE1

A Phase I, Open-label, Crossover Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs 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 rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.

Official title: A Phase I, Randomized, Open-label, 3 or 4-period, 7-treatment, Single-dose, Two Cohort, Crossover Study to Assess the Relative Bioavailability of Laroprovstat/Rosuvastatin 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

44

Start Date

2026-03-16

Completion Date

2026-05-29

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Laroprovstat Dose X STP

Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Rosuvastatin Dose 1 STP

Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

DRUG

Rosuvastatin Dose 2 STP

Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

Locations (2)

Research Site

Glendale, California, United States

Research Site

Brooklyn, Maryland, United States