Study Comparing the Safety and Body Processing of Trimedat 76.95 mg Orally Disintegrating Tablets and Trimedat 100 mg Tablets in Healthy Adults Ages 18 to 45

What this Trial Is About

Researchers are evaluating the pharmacokinetic profile, safety, and bioequivalence of Trimedat 76.95 mg orally disintegrating tablets compared to the reference Trimedat 100 mg tablets in healthy volunteers under fasted conditions. This Phase 1 study includes adults aged 18 to 45 years who are healthy and of Caucasian race. The study is sponsored by Valenta Pharm JSC and addresses conditions such as irritable bowel syndrome, gallstone disease, GERD, biliary dyskinesia, and postcholecystectomy syndrome. Participants are randomly assigned to one of two groups in a crossover design. Group 1 will take a 100 mg Trimedat tablet in the first period and a 76.95 mg orally disintegrating tablet in the second period. Group 2 will take these treatments in reverse order. Each participant receives a single dose of the assigned form under fasting conditions. The study monitors treatment sequences without masking or blinding. Volunteers undergo medical history reviews, physical exams, laboratory tests, and other diagnostic procedures to confirm health status before participation. Researchers will measure pharmacokinetic parameters such as maximum drug concentration Cmax, time to reach maximum concentration tmax, and drug clearance over 48 hours after drug intake. Safety is monitored throughout the study by tracking adverse events from screening to study completion. The total involvement includes initial screening, two dosing periods, and follow-up assessments lasting about 15 days.

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