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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07421011
Lead Sponsor Valenta Pharm JSC
Conditions
(from sponsor)		 Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia, Postcholecystectomy Syndrome
Related terms Biliary Dyskinesia, Cholelithiasis, Gastroesophageal Reflux, Irritable Bowel Syndrome, Postcholecystectomy Syndrome
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov