RecruitingPhase 1NCT07421011

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

A Randomized, Open-label, Crossover Study to Assess the Comparative Pharmacokinetics, Bioequivalence, and Safety of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.


Sponsor

Valenta Pharm JSC

Enrollment

36 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Trimedat® for people with biliary dyskinesia, gerd, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrimedat®

A single dose of R or T drug in each of 2 periods of the study under fasted conditions


Locations(1)

Federal Budgetary Institution of Science "North-West Public Health Research Center"

Saint Petersburg, Russia

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NCT07421011


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