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Tests treatment safety and results for Irritable Bowel Syndrome
Official title Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
ClinicalTrials.gov ID: NCT07421011
What this study is testing
What is Trimedat®?
Trimedat® is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for irritable bowel syndrome.
Also referred to as Trimebutine Maleate 100 mg Tablets.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- Heart rate (HR) from 60 to 89 beats per minute (inclusive);
You likely can't join 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...
- 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;
See the full eligibility criteria
Who can 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...
- 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-
- 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...
- 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 people 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...
- 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...
- 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...
- 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...
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.