NCT06342804

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

An Open-label Crossover Study With 2 Treatments (Fasting and Fed Conditions), 2 Periods, 2 Sequences to Evaluate the Effect of Food Intake on the Bioavailability of 4-MUST, Tablets, 128 mg at a Single Dose of 256 mg in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	4-MUST, 2 tablets, fasted	2 tablets (256 mg), fasted
DRUG	4-MUST, 2 tablets, after meals	2 tablets (256 mg), after meals

Timeline

• Start date: 2024-03-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: Russia