Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.

This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in healthy volunteers under fasted conditions.

NCT Number	NCT07421011
Lead Sponsor	Valenta Pharm JSC
Conditions	Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia, Postcholecystectomy Syndrome
Enrollment	36 participants
Start Date	2025-11-06
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-19