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RECRUITING
NCT07594977
PHASE1

Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

Sponsor: Valenta Pharm JSC

View on ClinicalTrials.gov

Summary

This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.

Official title: An Open-Label Study to Evaluate the Effect of Food on the Bioavailability of 4-MUST, 128 mg, Tablets and to Assess the Pharmacokinetics, Safety, and Tolerability Following Single and Multiple Dose Administration in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-01-26

Completion Date

2027-06-30

Last Updated

2026-05-19

Healthy Volunteers

Yes

Interventions

DRUG

4-MUST

128 mg tablets containing trimebutine 4-methylumbelliferyl sulfate (4-MUST)

Locations (1)

I.M. Sechenov First Moscow State Medical University

Moscow, Russia