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.

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; GERD; Biliary Dyskinesia; Postcholecystectomy Syndrome; Gallstone Disease
• Intervention / Treatment: Drug: Trimedat®

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russia
  • Saint Petersburg, Russia, 191036
    • Recruiting
    • Federal Budgetary Institution of Science "North-West Public Health Research Center"
    • Contact: Elena Shalukho; Phone Number: +7 (903) 099 57 86; Email: Elena.Shalukho@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT sequence: Trimedat® 100 mg Tablets followed by Trimedat® 76,95 mg Orally Disintegrating Tablets; Group 1 (18 volunteers, RT sequence) will take 1 tablet (100 mg) of Trimedat® in Period 1 and 1 Orally Disintegrating Tablet (76,95 mg) of Trimedat® in Period 2	Drug: Trimedat®; A single dose of R or T drug in each of 2 periods of the study under fasted conditions; Other Names: Trimebutine Maleate 100 mg Tablets
Active Comparator: TR sequence: Trimedat® 76,95 mg Orally Disintegrating Tablets followed by Trimedat® 100 mg Tablets; Group 2 (18 volunteers, TR sequence) will take 1 Orally Disintegrating Tablet (76,95 mg) of Trimedat® in Period 1 and 1 tablet (100 mg) of Trimedat® in Period 2	Drug: Trimedat®; A single dose of R or T drug in each of 2 periods of the study under fasted conditions; Other Names: Trimebutine Maleate 100 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics - number of terminal timepoints	Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant	From 0 to 24 hours after each drug intake.
Pharmacokinetics - Cmax	Maximum plasma concentration (Cmax) of N-desmethyltrimebutine (main metabolite of trimebutine)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - tmax	Time to reach Cmax (tmax)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - AUC0-t	Area under the plasma concentration-time curve from time 0 to t (AUC0-t)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - AUC0-inf	Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - AUCextr	Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf	From 0 to 48 hours after each drug intake.
Pharmacokinetics - t1/2	Elimination half-life (t1/2)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - kel	Elimination rate constant (kel)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - MRT	Mean residence time (MRT)	From 0 to 48 hours after each drug intake.
Pharmacokinetics - Vd	Volume of distribution	From 0 to 48 hours after each drug intake.
Pharmacokinetics - CL	Clearance (CL)	From 0 to 48 hours after each drug intake.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event type	Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.	From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event number	Number of adverse events registered during the study	From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Adverse event severety	Severity of adverse events registered during the study	From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Drop-outs associated with adverse events	The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug	From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Volunteer complaints	Description of complaints, recieved from volunteer	From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Physical examination results - cardiovascular system	An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - respiratory system	An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - digestive tract	An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - endocrine system	An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - musculoskeletal system	An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - nervous system	An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - sensory systems	An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - skin/visible mucous membranes	An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Physical examination results - genitourinary system	An assessment of the condition of the genitourinary system on physical examination (normal condition or list of abnormal conditions, if any)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: vital signs - systolic blood pressure	Systolic blood pressure (SBP, mmHg)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: vital signs - diastolic blood pressure	Diastolic blood pressure (DBP, mmHg)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: vital signs - heart rate	Heart rate (HR, bpm)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: vital signs - respiratory rate	Respiratory rate (breaths per minute)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)	Body temperature (Celsius temperature scale)	Screeninig (days -14 to -1), day -1 to 3, day 7 to 10
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QT interval	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QT interval (distance from the beginning of the QRS complex to the end of the T wave)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - hemoglobin	Hemoglobin (g/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - hematocrit	Hematocrit (%)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - red blood cell count	Red blood cell count (cells/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - platelet count	Platelet count (cells/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - leukocyte count	Leukocyte count (cells/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate	Erythrocyte sedimentation rate (mm/h)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - myelocytes	Leukocyte formula (myelocytes, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - band neutrophils	Leukocyte formula (band neutrophils, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - segmented neutrophils	Leukocyte formula (segmented neutrophils, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - eosinophils	Leukocyte formula (eosinophils, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - basophils	Leukocyte formula (basophils, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - monocytes	Leukocyte formula (monocytes, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: clinical blood test - lymphocytes	Leukocyte formula (lymphocytes, %)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - glucose	Glucose concentration (mmol/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - cholesterol	Total cholesterol concentration (mmol/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - total protein	Total protein in blood serum (g/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - bilirubin	Total bilirubin concentration (micromol/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - creatinine	Creatinine concentration (micromol/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - alkaline phosphatase	Alkaline phosphatase activity (U/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - alanine transaminase	Alanine transaminase activity (U/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: blood chemistry - aspartate transaminase	Aspartate transaminase activity (U/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - specific gravity	Specific gravity of the urine	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - color	Color of the urine	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - transparency	Transparency of the urine	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - pH	pH of the urine	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - protein	Protein concentration (g/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - glucose	Glucose concentration (mmol/L)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - red blood cells	Red blood cell content (number in sight)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - white blood cells	White blood cell content (number in sight)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - casts	Presence of casts (Yes/No)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - mucus	Presence of mucus (Yes/No)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis - bacteria	Presence of bacteria (Yes/No)	Screeninig (days -14 to -1), day 3, day 10
Safety and Tolerability: urinalysis (microscopy)	Microscopy of urine sediment is performed if it is present	Screeninig (days -14 to -1), day 3, day 10

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Biliary Tract Diseases; Colonic Diseases; Esophageal Diseases; Colonic Diseases, Functional; Bile Duct Diseases; Esophageal Motility Disorders; Deglutition Disorders; Common Bile Duct Diseases; Pathological Conditions, Signs and Symptoms; Irritable Bowel Syndrome; Gastroesophageal Reflux; Cholelithiasis; Biliary Dyskinesia; Postcholecystectomy Syndrome; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Hydroxybenzoates; Phenyl Ethers; Hydroxybenzoate Ethers; Trimebutine
• Other Study ID Numbers: TMD-05-02-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No