Irritable Bowel SyndromePhase 1NCT07421011
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
A Phase 1 study testing Trimedat® in people with Irritable Bowel Syndrome and Gallstone Disease, run by Valenta Pharm JSC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Gallstone Disease, GERD
- What is being tested?
- Trimedat®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 6 Nov 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Show all 39Show fewer
- 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;
- Participation in another clinical study within 3 months prior to screening or concurrently with this study;
- 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;
- 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;
- Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;
- 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;
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;
- 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;
- ECG abnormalities in medical history and/or during screening;
- Positive urine test for narcotic substances and potent medications during screening;
- Positive breath alcohol test result during screening;
- Planning hospitalization during the study period for any reason other than hospitalization specified in the study protocol;
- Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;
- 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;
- 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).
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal Budgetary Institution of Science "North-West Public Health Research Center"
Saint Petersburg, 191036
Elena Shalukho, +7 (903) 099 57 86, Elena.Shalukho@yandex.ru
About this study
Official title: 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.
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia, Postcholecystectomy Syndrome
- Being tested
- Trimedat®
- Medical subject headings
- Irritable Bowel Syndrome, Cholelithiasis, Gastroesophageal Reflux, Biliary Dyskinesia, Postcholecystectomy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimedat®Drug
Also called Trimebutine Maleate 100 mg Tablets
A single dose of R or T drug in each of 2 periods of the study under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| RT sequence: Trimedat® 100 mg Tablets followed by Trimedat® 76,95 mg Orally Disintegrating Tablets | Experimental | 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 Receives: Drug: Trimedat® |
| TR sequence: Trimedat® 76,95 mg Orally Disintegrating Tablets followed by Trimedat® 100 mg Tablets | Active comparator | 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 Receives: Drug: Trimedat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of N-desmethyltrimebutine (main metabolite of trimebutine)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Measured: 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)
Measured: 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)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - AUCextr
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - t1/2
Elimination half-life (t1/2)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - kel
Elimination rate constant (kel)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - MRT
Mean residence time (MRT)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - Vd
Volume of distribution
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - CL
Clearance (CL)
Measured: From 0 to 48 hours after each drug intake.
Pharmacokinetics - number of terminal timepoints
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Measured: From 0 to 24 hours after each drug intake.
Secondary outcomes (1)
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.
Measured: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start6 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421011
- Sponsor's protocol ID
- TMD-05-02-2025
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07421011
- Acronym / sponsor ID
- TMD-05-02-2025
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia, Postcholecystectomy Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT sequence: Trimedat® 100 mg Tablets followed by Trimedat® 76,95 mg Orally Disintegrating Tablets | Experimental | Drug: Trimedat®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 |
| TR sequence: Trimedat® 76,95 mg Orally Disintegrating Tablets followed by Trimedat® 100 mg Tablets | Active comparator | Drug: Trimedat®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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (39 listed)
- 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);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimedat®Also: Trimebutine Maleate 100 mg TabletsA single dose of R or T drug in each of 2 periods of the study under fasted conditions | Drug | RT sequence: Trimedat® 100 mg Tablets followed by Trimedat® 76,95 mg Orally Disintegrating Tablets, TR sequence: Trimedat® 76,95 mg Orally Disintegrating Tablets followed by Trimedat® 100 mg Tablets |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 48 hours after each drug intake.
Maximum plasma concentration (Cmax) of N-desmethyltrimebutine (main metabolite of trimebutine)
Pharmacokinetics - tmax
Time frame: From 0 to 48 hours after each drug intake.
Time to reach Cmax (tmax)
Pharmacokinetics - AUC0-t
Time frame: From 0 to 48 hours after each drug intake.
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Pharmacokinetics - AUC0-inf
Time frame: From 0 to 48 hours after each drug intake.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Pharmacokinetics - AUCextr
Time frame: From 0 to 48 hours after each drug intake.
Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Pharmacokinetics - t1/2
Time frame: From 0 to 48 hours after each drug intake.
Elimination half-life (t1/2)
Pharmacokinetics - kel
Time frame: From 0 to 48 hours after each drug intake.
Elimination rate constant (kel)
Pharmacokinetics - MRT
Time frame: From 0 to 48 hours after each drug intake.
Mean residence time (MRT)
Pharmacokinetics - Vd
Time frame: From 0 to 48 hours after each drug intake.
Volume of distribution
Pharmacokinetics - CL
Time frame: From 0 to 48 hours after each drug intake.
Clearance (CL)
Pharmacokinetics - number of terminal timepoints
Time frame: From 0 to 24 hours after each drug intake.
Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
1 secondary outcome
Adverse event type
Time frame: From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Related trials for Irritable Bowel Syndrome
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Not yet recruitingPhase 1
SIMBA in Irritable Bowel Syndrome (IBS)
Irritable Bowel Syndrome (IBS), Microbiome
Not yet recruiting
Psyllium Husk in Pediatric IBS
Prebiotic, IBS (Irritable Bowel Syndrome)
Recruiting
IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federal Budgetary Institution of Science "North-West Public Health Research Center"
Saint Petersburg, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trimedat® in people with Irritable Bowel Syndrome and Gallstone Disease, run by Valenta Pharm JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 48 hours after each drug intake.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.