Comparing Trimedat 76.95 mg orally disintegrating tablets with Trimedat 100 mg tablets in healthy adults

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.

This will test if Trimedat 76.95 mg dissolving tablets work the same and are as safe as Trimedat 100 mg tablets when taken fasting by healthy adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Valenta Pharm JSC (industry)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT07421011 on ClinicalTrials.gov

What this trial studies

This Phase 1 study enrolls healthy adult volunteers who will receive the investigational Trimedat 76.95 mg orally disintegrating tablets and the reference Trimedat 100 mg tablets under fasted conditions to compare pharmacokinetic profiles and safety. Blood samples will be collected over a defined period to measure drug concentrations and calculate key PK parameters such as peak concentration and exposure. Safety monitoring includes vital signs, laboratory tests, and recording of any adverse events. The primary objective is to establish bioequivalence between the two formulations to support interchangeable use.

Who should consider this trial

Good fit: Healthy Caucasian men and women aged 18–45 with BMI 18.5–30 kg/m2 who meet specified vital sign and laboratory criteria and agree to required contraception and study procedures are ideal candidates.

Not a fit: People with active gastrointestinal disease, those outside the healthy volunteer age or health criteria, or those seeking immediate treatment benefit are unlikely to receive direct benefit from participating.

Why it matters

Potential benefit: If successful, this could provide an orally disintegrating Trimedat option that is interchangeable with the 100 mg tablet and easier to take for people who have trouble swallowing.

How similar studies have performed: Formulation bioequivalence and single-dose pharmacokinetic studies like this are common and have frequently demonstrated equivalent blood levels for alternative tablet formulations.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;
2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.;
3. 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;
4. 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);
5. Heart rate (HR) from 60 to 89 beats per minute (inclusive);
6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);
7. Body temperature from 36.0°C to 36.9°C (inclusive);
8. 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;
9. 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:

1. Clinically significant allergic history;
2. Hypersensitivity to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
3. Drug intolerance to active and/or excipient substances in the investigational drug and comparator drug in the medical history;
4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
5. 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;
6. Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);
7. Diseases/conditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;
8. Acute infectious diseases less than 4 weeks before screening;
9. Use of drugs that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;
10. 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);
11. Blood or plasma donating within 3 months prior to screening;
12. Use of hormonal contraceptives (in women) within 2 months prior to screening;
13. Use of depot injections of any medications within 3 months prior to screening;
14. Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;
15. Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;
16. Participation in another clinical study within 3 months prior to screening or concurrently with this study;
17. Consumption of more than 10 alcohol units per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine, or 50 ml of strong alcoholic beverages) in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse;
18. Smoking more than 10 cigarettes per day currently or smoking that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during hospitalization;
19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;
20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or preparations/products containing St. John's wort within 7 days prior to taking investigational drugs;
21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;
22. Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens during screening;
23. ECG abnormalities in medical history and/or during screening;
24. Positive urine test for narcotic substances and potent medications during screening;
25. Positive breath alcohol test result during screening;
26. Planning hospitalization during the study period for any reason other than hospitalization specified in the study protocol;
27. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;
28. Membership in a vulnerable population, including but not limited to students of medical, pharmaceutical and dental educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, military personnel, prisoners, residents of care facillities, individuals with low income or unemployed, members of ethnic minorities, homeless persons, vagrants, refugees, individuals under guardianship or conservatorship, individuals unable to provide informed consent and law enforcement personnel;
29. Other conditions that in the judgment of the Investigator may prevent volunteer inclusion in the study or lead to premature withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or special lifestyles (night work, extreme physical exertion).

Exclusion Criteria:

1. Withdrawal of the volunteer from further participation in the study;
2. 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.);
3. Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
4. Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;
5. Development of a severe and/or serios adverse event (AE/SAE) in the volunteer during the study;
6. The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;
7. Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;
8. Occurrence of vomiting/diarrhea within 6 hours after taking the investigational drug;
9. Positive urine test for narcotic substances and potent medications;
10. Positive breath test for alcohol vapors;
11. Positive pregnancy test result in women;
12. Emergence of other circumstances during the study that preclude conducting the study according to the protocol.

Where this trial is running

Saint Petersburg

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

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