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Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers

NCT06315387 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-03-18

No results posted yet for this study

Summary

Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers

Conditions

  • Cholecystitis

Interventions

DRUG

4-MUST, 1 tablet

4-methylumbelliferyl trimebutine sulfate, 128 mg

DRUG

4-MUST, 2 tablets

4-methylumbelliferyl trimebutine sulfate, 256 mg

DRUG

4-MUST, 3 tablets

4-methylumbelliferyl trimebutine sulfate, 384 mg

Sponsors & Collaborators

  • Valenta Pharm JSC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Russia

Study Locations

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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 NCT06315387 on ClinicalTrials.gov