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A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults

NCT07316608 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Healthy Participants

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-05-29
Completion
2026-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316608 on ClinicalTrials.gov