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

Recruiting now · Phase 1

Conditions studied: Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia, Postcholecystectomy Syndrome

In brief

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.

Key facts

Study ID

NCT07421011

Run by

Valenta Pharm JSC

People needed

36

Starts

2025-11-06

Expected to finish

2026-12-31

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;
• Males and females aged 18 to 45 years (inclusive) of Caucasian race.;
• Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical and instrumental examination, laboratory tests, and other diagnostic procedures specified in the protocol;
• Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
• Heart rate (HR) from 60 to 89 beats per minute (inclusive);
• Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);
• Body temperature from 36.0°C to 36.9°C (inclusive);
• Body mass index (BMI) between 18.5 kg/m² and 30 kg/m², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;
• Consent to use adequate contraceptive methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of childbearing potential.
• Non-Inclusion Criteria:
• Clinically significant allergic history;
• Hypersensitivity to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
• Drug intolerance to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
• Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
• Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye;
• Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);
• Diseases/conditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;
• Acute infectious diseases less than 4 weeks before screening;
• Use of drugs that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;
• Regular use of medications less than 2 weeks before screening and single use of medications less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines);
• Blood or plasma donating within 3 months prior to screening;
• Use of hormonal contraceptives (in women) within 2 months prior to screening;
• Use of depot injections of any medications within 3 months prior to screening;
• Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;
• Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;

You may not qualify if…

• Withdrawal of the volunteer from further participation in the study;
• Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
• Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
• Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;
• Development of a severe and/or serios adverse event (AE/SAE) in the volunteer during the study;
• The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;
• Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;
• Occurrence of vomiting/diarrhea within 6 hours after taking the investigational drug;
• Positive urine test for narcotic substances and potent medications;
• Positive breath test for alcohol vapors;
• Positive pregnancy test result in women;
• Emergence of other circumstances during the study that preclude conducting the study according to the protocol.

Where it is running

• Federal Budgetary Institution of Science "North-West Public Health Research Center" — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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