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RecruitingNCT07421011Updated Feb 19, 2026

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

A Phase 1 interventional study of Trimedat® in Irritable Bowel Syndrome, Gallstone Disease and GERD, sponsored by Valenta Pharm JSC. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Valenta Pharm JSC · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome
  • Gallstone Disease
  • GERD
  • Biliary Dyskinesia
  • Postcholecystectomy Syndrome
03

In context

Irritable Bowel Syndrome

1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.

This study's planned enrollment of 36 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.

Browse Valenta Pharm JSC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily and personally signed 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 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. (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 methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of .

Non-Inclusion Criteria:

  1. Clinically significant allergic history;
  2. to active and/or substances in the 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 (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, surface antigen (HBsAg), antibodies to virus antigens during screening;
  23. 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

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., 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 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • 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®

  • 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®

Interventions

  • DrugTrimedat®

    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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - Cmax

    Maximum plasma concentration (Cmax) of N-desmethyltrimebutine (main metabolite of trimebutine)

    Time frame: From 0 to 48 hours after each drug intake.

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax)

    Time frame: From 0 to 48 hours after each drug intake.

  3. Pharmacokinetics - AUC0-t

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

    Time frame: From 0 to 48 hours after each drug intake.

  4. Pharmacokinetics - AUC0-inf

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Time frame: From 0 to 48 hours after each drug intake.

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Time frame: From 0 to 48 hours after each drug intake.

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2)

    Time frame: From 0 to 48 hours after each drug intake.

  7. Pharmacokinetics - kel

    Elimination rate constant (kel)

    Time frame: From 0 to 48 hours after each drug intake.

  8. Pharmacokinetics - MRT

    Mean residence time (MRT)

    Time frame: From 0 to 48 hours after each drug intake.

  9. Pharmacokinetics - Vd

    Volume of distribution

    Time frame: From 0 to 48 hours after each drug intake.

  10. Pharmacokinetics - CL

    Clearance (CL)

    Time frame: From 0 to 48 hours after each drug intake.

  11. Pharmacokinetics - number of terminal timepoints

    Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant

    Time frame: 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.

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

Other outcomes

  1. Adverse event number

    Number of adverse events registered during the study

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

  2. Adverse event severety

    Severity of adverse events registered during the study

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

  3. 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

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

  4. Volunteer complaints

    Description of complaints, recieved from volunteer

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

  5. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  6. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  7. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  8. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  9. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  11. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  12. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  13. 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)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  14. Safety and Tolerability: vital signs - systolic blood pressure

    Systolic blood pressure (SBP, mmHg)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  15. Safety and Tolerability: vital signs - diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  16. Safety and Tolerability: vital signs - heart rate

    Heart rate (HR, bpm)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  17. Safety and Tolerability: vital signs - respiratory rate

    Respiratory rate (breaths per minute)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  18. Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)

    Body temperature (Celsius temperature scale)

    Time frame: Screeninig (days -14 to -1), day -1 to 3, day 7 to 10

  19. 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)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  20. 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)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  21. 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)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  22. 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)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  23. Safety and Tolerability: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  24. Safety and Tolerability: clinical blood test - hematocrit

    Hematocrit (%)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  25. Safety and Tolerability: clinical blood test - red blood cell count

    Red blood cell count (cells/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  26. Safety and Tolerability: clinical blood test - platelet count

    Platelet count (cells/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  27. Safety and Tolerability: clinical blood test - leukocyte count

    Leukocyte count (cells/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  28. Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate (mm/h)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  29. Safety and Tolerability: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  30. Safety and Tolerability: clinical blood test - band neutrophils

    Leukocyte formula (band neutrophils, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  31. Safety and Tolerability: clinical blood test - segmented neutrophils

    Leukocyte formula (segmented neutrophils, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  32. Safety and Tolerability: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  33. Safety and Tolerability: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  34. Safety and Tolerability: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  35. Safety and Tolerability: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  36. Safety and Tolerability: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  37. Safety and Tolerability: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  38. Safety and Tolerability: blood chemistry - total protein

    Total protein in blood serum (g/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  39. Safety and Tolerability: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  40. Safety and Tolerability: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  41. Safety and Tolerability: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  42. Safety and Tolerability: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  43. Safety and Tolerability: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  44. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  45. Safety and Tolerability: urinalysis - color

    Color of the urine

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  46. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  47. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  48. Safety and Tolerability: urinalysis - protein

    Protein concentration (g/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  49. Safety and Tolerability: urinalysis - glucose

    Glucose concentration (mmol/L)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  50. Safety and Tolerability: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  51. Safety and Tolerability: urinalysis - white blood cells

    White blood cell content (number in sight)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  52. Safety and Tolerability: urinalysis - casts

    Presence of casts (Yes/No)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  53. Safety and Tolerability: urinalysis - mucus

    Presence of mucus (Yes/No)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  54. Safety and Tolerability: urinalysis - bacteria

    Presence of bacteria (Yes/No)

    Time frame: Screeninig (days -14 to -1), day 3, day 10

  55. Safety and Tolerability: urinalysis (microscopy)

    Microscopy of urine sediment is performed if it is present

    Time frame: Screeninig (days -14 to -1), day 3, day 10

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2026
First posted
Feb 19, 2026
StartActual
Nov 6, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07421011
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Nov 6, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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