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CompletedNCT06552624Updated Aug 14, 2024

Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers

An interventional study of Magaldrate and Magaldrate in Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract and Symptomatic Treatment of Gastric and Duodenal Ulcers, sponsored by Valenta Pharm JSC. Completed at 3 sites in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Valenta Pharm JSC · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jul 2021, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg chewable tablets and drug Riopan 800 mg chewable tablets in healthy volunteers.

02

Conditions studied

  • Heartburn
  • Acid-dependent Diseases of the Gastrointestinal Tract
  • Symptomatic Treatment of Gastric and Duodenal Ulcers
03

In context

Heartburn

154 studies on the registry are indexed under Heartburn; 12 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 127 interventional studies indexed under Heartburn.

Browse Heartburn 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. Voluntary and handwritten form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
  2. Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);
  3. Verified diagnosis "healthy" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);
  4. pH according to hourly pH-metry in the screening period, carried out at least 3 hours after the last meal, is completely in the range from 1 to 3 inclusive throughout the entire astronomical hour of measurement;
  5. Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);
  6. Heart rate (HR) of 60 to 90 bpm, inclusive;
  7. (BMI) of 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2, where the body weight range is ≥ 55 kg for men and ≥ 45 kg for women;
  8. Non-smoking healthy volunteers (who have never smoked or gave up smoking more than 6 months prior to the Screening);
  9. Consent to use adequate methods of throughout the study and for 30 days after completion; for women of preserved , a negative urine pregnancy test result;
  10. The volunteers must have adequate behavior and coherent speech.

Exclusion criteria

Exclusion Criteria:

  1. A history of allergy;
  2. History of drug intolerance to the active substance and/or included in the study drugs;
  3. History of drug intolerance of or /allergic reactions to lidocaine, xylocaine or other topical anesthetics which will be used at the trial site for anesthesia during esophagogastroduodenoscopy (EGD) and insertion of the probe for the pH measurements;
  4. Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune, urogenital, and hematopoietic systems;
  5. Esophageal, gastric, and/or duodenal diseases based on EGD performed at screening and based on the medical history; a history of esophageal, gastric, and/or duodenal surgery;
  6. Diseases/conditions which, in the opinion of the investigator, may affect the pH measurement results;
  7. Acute infectious diseases less than 4 weeks prior to screening;
  8. Use of antacids (including sodium bicarbonate solution)/H2 antagonists 24 h prior to the Screening Visit;
  9. Use of proton pump inhibitors 72 h prior to the Screening Visit;
  10. Use of (including use of a single dose) and/or other ulcerogenic drug (e.g., nonsteriodal anti-inflammatory drugs [NSAID]) less than 4 weeks prior to the Screening Visit;
  11. Regular use of any medicinal products, including prescription only and OTC (Over-the-counter) drugs and dietary supplements within 2 weeks prior to the Screening Visit;
  12. Blood or plasma donation less than 3 months prior to the Screening Visit;
  13. Use of hormonal (in women) less than 2 months prior to the Screening Visit;
  14. Pregnancy or breastfeeding; a positive pregnancy test for women of ;
  15. Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study;
  16. Use of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine or 40 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol/drug dependence or drug abuse.
  17. Positive antibody blood test for -1 and HIV-2, Treponema pallidum antigen, surface antigen (HBsAg), or virus antigen;
  18. Positive urine test for narcotic substances or strong drugs;
  19. Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test;
  20. Deviated septum/nasal obstruction preventing the placement of the pH probe;
  21. Medical history of chronic constipation;
  22. Medical history of severe maxillofacial injuries;
  23. Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol;
  24. Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime;
  25. Other circumstances which in the opinion of the investigator prevent a volunteer from being included in the study or may result in premature drop-out from the study.

Withdrawal criteria:

  1. The volunteer's refusal to further participate in the study;
  2. Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
  3. Taking prohibited therapy;
  4. Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer, including severe AEs;
  5. Volunteers selected to participate in the study in violation of the inclusion/non-inclusion criteria;
  6. Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.);
  7. Missing a dose of the study drug/comparator drug during any period of the study for any reason;
  8. Positive urine test for narcotics and strong drugs;
  9. Positive breath alcohol vapor test or alcohol in saliva;
  10. Positive pregnancy test in women;
  11. The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Terms in these criteria, in plain language(11)

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.

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.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Excipients

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

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    TR-sequence (T-test drug, R-reference drug)

    Group 1 (20 volunteers, TR sequence) will take 2 tablets of Antareit (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 tablets of Riopan (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 2

    Drug: Magaldrate

  • Experimental
    RT-sequence

    Group 2 (20 volunteers, RT sequence) will take 2 tablets of Riopan (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 tablets of Antareit (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 2

    Drug: Magaldrate

Interventions

  • DrugMagaldrate

    A dose of T drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day

    Also known as: Antareit (T)

  • DrugMagaldrate

    A dose of R drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day

    Also known as: Riopan (R)

06

What researchers measure

Primary outcomes

  1. Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline

    Area under the pharmacodynamic pH-time curve adjusted to baseline (before drug intake)

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

Secondary outcomes

  1. Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0

    PH - potential of hydrogen

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  2. Pharmacodynamics - рН maximum

    Maximum potential of hydrogen

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  3. Pharmacodynamics - рН minimum

    Minimum potential of hydrogen

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  4. Pharmacodynamics - average pH value

    Root mean square

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  5. Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0

    Time during which the intragastric pH value will exceed 3.0

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  6. Pharmacodynamics - median time when the pH was above 3.0

    Time during which the intragastric pH value will be above 3.0

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  7. Pharmacodynamics - median time when the pH was above 4.0

    Time during which the intragastric pH value will be above 4.0

    Time frame: From 0 to 1 hour (Day 1 and Day 8)

  8. Safety and Tolerability: adverse event (AE) number and frequency

    Number and frequency of adverse events (AEs) or serious AEs (SAEs)

    Time frame: From the screening (and signing informed consent form) to Day 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)

  9. Safety and Tolerability: serious adverse event (SAE) number and frequency

    Number and frequency of serious AEs (SAEs)

    Time frame: From the screening (and signing informed consent form) to Day 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)

  10. Safety and Tolerability: volunteer complaints

    Description of complaints, recieved from volunteer

    Time frame: From the screening (and signing informed consent form) to Day 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)

  11. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  12. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  13. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  14. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  15. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  16. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  17. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  18. Safety and Tolerability: 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: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

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

    Systolic blood pressure (SBP, mmHg)

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

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

    Diastolic blood pressure (DBP, mmHg)

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  21. Safety and Tolerability: vital signs - heart rate

    Heart rate (HR, bpm)

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

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

    Body temperature (Celsius temperature scale)

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 15)

  23. 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: Screening, Day 9

  24. 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: Screening, Day 9

  25. 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: Screening, Day 9

  26. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected 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: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)

    Time frame: Screening, Day 9

  27. Safety and Tolerability: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Time frame: Screening, Day 2, Day 9

  28. Safety and Tolerability: clinical blood test - hematocrit

    hematocrit (%)

    Time frame: Screening, Day 2, Day 9

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

    Red blood cell count (cells/L)

    Time frame: Screening, Day 2, Day 9

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

    Platelet count (cells/L)

    Time frame: Screening, Day 2, Day 9

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

    Leukocyte count (cells/L)

    Time frame: Screening, Day 2, Day 9

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

    Erythrocyte sedimentation rate (m/h)

    Time frame: Screening, Day 2, Day 9

  33. Safety and Tolerability: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Time frame: Screening, Day 2, Day 9

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

    Leukocyte formula (band neutrophils, %)

    Time frame: Screening, Day 2, Day 9

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

    Leukocyte formula (segmented neutrophils, %)

    Time frame: Screening, Day 2, Day 9

  36. Safety and Tolerability: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Time frame: Screening, Day 2, Day 9

  37. Safety and Tolerability: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Time frame: Screening, Day 2, Day 9

  38. Safety and Tolerability: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Time frame: Screening, Day 2, Day 9

  39. Safety and Tolerability: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Time frame: Screening, Day 2, Day 9

  40. Safety and Tolerability: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Time frame: Screening, Day 2, Day 9

  41. Safety and Tolerability: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Time frame: Screening, Day 2, Day 9

  42. Safety and Tolerability: blood chemistry - protein

    Total protein concentration (g/L)

    Time frame: Screening, Day 2, Day 9

  43. Safety and Tolerability: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Time frame: Screening, Day 2, Day 9

  44. Safety and Tolerability: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Time frame: Screening, Day 2, Day 9

  45. Safety and Tolerability: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Time frame: Screening, Day 2, Day 9

  46. Safety and Tolerability: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Time frame: Screening, Day 2, Day 9

  47. Safety and Tolerability: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Time frame: Screening, Day 2, Day 9

  48. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Time frame: Screening, Day 2, Day 9

  49. Safety and Tolerability: urinalysis - color

    Color of the urine

    Time frame: Screening, Day 2, Day 9

  50. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Time frame: Screening, Day 2, Day 9

  51. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Time frame: Screening, Day 2, Day 9

  52. Safety and Tolerability: urinalysis - protein

    Protein concentration (g/L)

    Time frame: Screening, Day 2, Day 9

  53. Safety and Tolerability: urinalysis - glucose

    Glucose concentration (mmol/L)

    Time frame: Screening, Day 2, Day 9

  54. Safety and Tolerability: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Time frame: Screening, Day 2, Day 9

  55. Safety and Tolerability: urinalysis - white blood cells

    White blood cell content (number in sight)

    Time frame: Screening, Day 2, Day 9

  56. Safety and Tolerability: urinalysis - epithelial cells

    Epithelial cell content (number in sight)

    Time frame: Screening, Day 2, Day 9

  57. Safety and Tolerability: urinalysis - casts

    Presence of casts (Yes/No)

    Time frame: Screening, Day 2, Day 9

  58. Safety and Tolerability: urinalysis - mucus

    Presence of mucus (Yes/No)

    Time frame: Screening, Day 2, Day 9

  59. Safety and Tolerability: urinalysis - bacteria

    Presence of bacteria (Yes/No)

    Time frame: Screening, Day 2, Day 9

  60. Safety and Tolerability: urinalysis (microscopy)

    Microscopy of urine sediment is performed if it is present

    Time frame: Screening, Day 2, Day 9

07

Study locations

3 sites
  • Llc "Certa Clinic"
    Moscow, 109235, Russian Federation
  • Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
    Saint Petersburg, 195271, Russian Federation
  • Limited Liability Company "Research Center Eco-Safety"
    Saint Petersburg, 196143, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Aug 2022, 13 months.

Of 26 interventional studies with no phase under Heartburn, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 13 months is below that.

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

Registered
Jul 19, 2024
First posted
Aug 14, 2024
StartActual
Jul 7, 2021
Primary completionActual
Aug 31, 2022
CompletionActual
Aug 31, 2022
Last update
Aug 14, 2024
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 Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06552624
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Aug 14, 2024
Start date
Jul 7, 2021
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Aug 14, 2024

Oversight

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

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