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

NCT07421011 | Recruiting Phase 1

• 1 other identifier: TMD-05-02-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome; Gallstone Disease; GERD; Biliary Dyskinesia; Postcholecystectomy Syndrome

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

Secondary Outcomes (1)

• Adverse event type

  From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

Other Outcomes (55)

• Adverse event number

  From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

• Adverse event severety

  From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

• Drop-outs associated with adverse events

  From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

Study Arms (2)

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

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

Drug: Trimedat®

Interventions

Trimedat® DRUG

A single dose of R or T drug in each of 2 periods of the study under fasted conditions

Also known as: Trimebutine Maleate 100 mg Tablets

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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);

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.);
• 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.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (1)

Federal Budgetary Institution of Science "North-West Public Health Research Center"

Saint Petersburg, 191036, Russia

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Cholelithiasis; Gastroesophageal Reflux; Biliary Dyskinesia; Postcholecystectomy Syndrome

Interventions

Trimebutine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Biliary Tract Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 19, 2026
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

RU (1)