NCT06315387

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

Open Study of Safety, Tolerability and Pharmacokinetic Parameters of Increasing Doses of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Subsequent Multiple Oral Administration in Healthy Volunteers.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Russia