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Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg

NCT06342804 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-02

No results posted yet for this study

Summary

Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).

Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).

Conditions

  • Cholecystitis

Interventions

DRUG

4-MUST, 2 tablets, fasted

2 tablets (256 mg), fasted

DRUG

4-MUST, 2 tablets, after meals

2 tablets (256 mg), after meals

Sponsors & Collaborators

  • Valenta Pharm JSC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-03-19
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 NCT06342804 on ClinicalTrials.gov