HeartburnNCT06098742
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers
A study testing Antareit in people with Heartburn and Acid-dependent Diseases of the Gastrointestinal Tract, run by Valenta Pharm JSC at 2 sites in Russia.
Trial summary
Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg/10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers
- What is being tested?
- Antareit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesRussia
- Study dates
- 25 Apr 2024to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);
- Verified diagnosis "healthy" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);
- 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;
- Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);
- Heart rate (HR) of 60 to 90 bpm, inclusive;
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- Body mass index (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;
- Non-smoking healthy volunteers (who have never smoked or gave up smoking more than 6 months prior to the Screening);
- Consent to use adequate methods of contraception throughout the study and for 30 days after completion; for women of preserved reproductive potential, a negative urine pregnancy test result;
- The volunteers must have adequate behavior and coherent speech.
Who cannot join
- A history of allergy;
- History of drug intolerance to the active and/or excipients included in the study drugs;
- History of drug intolerance of or hypersensitivity/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;
- Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune, urogenital, and hematopoietic systems;
- Esophageal, gastric, and/or duodenal diseases based on EGC performed at screening and based on the medical history; a history of esophageal, gastric, and/or duodenal surgery;
- Diseases/conditions which, in the opinion of the investigator, may affect the pH measurement results;
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- Acute infectious diseases less than 4 weeks prior to screening;
- Use of antacids (including sodium bicarbonate solution)/H2 antagonists 24 h prior to the Screening Visit;
- Use of proton pump inhibitors 72 h prior to the Screening Visit;
- Use of (including use of a single dose) steroids and/or other ulcerogenic drug (e.g., nonsteriodal anti-inflammatory drugs [NSAID]) less than 4 weeks prior to the Screening Visit;
- 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;
- Blood or plasma donation less than 3 months prior to the Screening Visit;
- Use of hormonal contraceptives (in women) less than 2 months prior to the Screening Visit;
- Pregnancy or breastfeeding; a positive pregnancy test for women of childbearing potential;
- Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study;
- 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.
- Positive antibody blood test for HIV-1 and HIV-2, Treponema pallidum antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus antigen;
- Positive urine test for narcotic substances or strong drugs;
- Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test;
- Deviated septum/nasal obstruction preventing the placement of the pH probe;
- Medical history of chronic constipation;
- Medical history of severe maxillofacial injuries;
- Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol;
- Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime;
- Positive SARS-CoV-2 (severe acute respiratory syndrome related coronavirus) (COVID-19) rapid test;
- 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:
- The volunteer's refusal to further participate in the study;
- 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.);
- Taking prohibited therapy;
- Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer, including severe AEs;
- Volunteers selected to participate in the study in violation of the inclusion/non-inclusion criteria;
- Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.);
- Missing a dose of the study drug/comparator drug during any period of the study for any reason;
- Positive urine test for narcotics and powerful drugs;
- Positive breath alcohol vapor test or alcohol in saliva;
- Positive pregnancy test in women;
- Positive test for COVID-19;
- The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Llc "Certa Clinic"
Moscow, 109235
Alexander S Goncharov, MD, +7 (495) 121 07 05, info@certa-clinic.ru
- Recruiting
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
Konstantin Zakharov, MD, +7 921 950 29 91, konstantin.zakharov@mail.ru
About this study
Official title: An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers.
Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg/10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers.
- Conditions
- Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers
- Being tested
- Antareit
- Medical subject headings
- Heartburn, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntareitDrug
A single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake
| Study group | Role | What they receive |
|---|---|---|
| TR-sequence (T-test drug, R-reference drug) | Experimental | Group 1 (25 volunteers, TR sequence) will take 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 1 and 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 2 Receives: Drug: Antareit |
| RT-sequence | Experimental | Group 2 (25 volunteers, RT sequence) will take 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 2 Receives: Drug: Antareit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen
Area under the pharmacodynamic pH-time curve
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
PH - potential of hydrogen
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmaximum
maximum potential of hydrogen
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmin
minimum potential of hydrogen
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - average pH value
root mean square
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
During which the intragastric pH value will exceed 3.0
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 3.0
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 4.0
Measured: From 0 to 1 hour (Day 1 and Day 8)
Secondary outcomes (10)
Safety and Tolerability: adverse event (AE) number and frequency
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: 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)
Safety and Tolerability: serious adverse event (SAE) number and frequency
Number and frequency of serious AEs (SAEs)
Measured: 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)
Safety and Tolerability: volunteer complaints
Measured: 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)
Safety and Tolerability: physical examination results
Physical examination will be conducted to identify normal and abnormal physical characteristics of volunteers in accordance with the planned examination and will include an assessment of the Condition of the cardiovascular, respiratory, digestive, endocrine, musculoskeletal, nervous, sensory systems, skin/visible mucous membranes
Measured: 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)
Safety and Tolerability: vital signs
systolic blood pressure (SBP),diastolic blood pressure (DBP), heart rate (HR), body temperature
Measured: 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)
Safety and Tolerability: 12-lead electrocardiogram (ECG)
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 legб V1-V6) taken while lying down: heart rate (beats per minute), 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), QRS complex (The QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram), corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Measured: Screening, Day 9
Safety and Tolerability: clinical blood test
hemoglobin, hematocrit, Red blood cell count, Platelet count, Leukocyte count, erythrocyte sedimentation rate, Leukocyte formula (myelocytes, band neutrophils, segmented neutrophils, eosinophils, basophils, monocytes, lymphocytes)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry
Glucose concentration, Total cholesterol concentration, Total protein concentration, Total bilirubin concentration, Creatinine concentration, Alkaline phosphatase activity, alanine transaminase and aspartate transaminase activity
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis
Relative density, Color, Transparency, pH, Protein concentration, Glucose concentration, Red blood cell content, White blood cell content, Epithelial cell content, Presence of casts, Presence of mucus, Presence of bacteria.
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present.
Measured: Screening, Day 2, Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start25 Apr 2024
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06098742
- Sponsor's protocol ID
- ANT-05-01-2022
- Status last verified
- Jul 2024
- First submitted
- 19 Oct 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06098742
- Acronym / sponsor ID
- ANT-05-01-2022
- Conditions
- Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg/10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR-sequence (T-test drug, R-reference drug) | Experimental | Drug: AntareitGroup 1 (25 volunteers, TR sequence) will take 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 1 and 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 2 |
| RT-sequence | Experimental | Drug: AntareitGroup 2 (25 volunteers, RT sequence) will take 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;
- Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);
- Verified diagnosis "healthy" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);
- 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;
- Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);
Key exclusion criteria (39 listed)
- A history of allergy;
- History of drug intolerance to the active and/or excipients included in the study drugs;
- History of drug intolerance of or hypersensitivity/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;
- Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune, urogenital, and hematopoietic systems;
- Esophageal, gastric, and/or duodenal diseases based on EGC performed at screening and based on the medical history; a history of esophageal, gastric, and/or duodenal surgery;
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 |
|---|---|---|
| AntareitA single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake | Drug | RT-sequence, TR-sequence (T-test drug, R-reference drug) |
Primary outcome
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Area under the pharmacodynamic pH-time curve
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
PH - potential of hydrogen
Pharmacodynamics- рНmaximum
Time frame: From 0 to 1 hour (Day 1 and Day 8)
maximum potential of hydrogen
Pharmacodynamics- рНmin
Time frame: From 0 to 1 hour (Day 1 and Day 8)
minimum potential of hydrogen
Pharmacodynamics - average pH value
Time frame: From 0 to 1 hour (Day 1 and Day 8)
root mean square
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
During which the intragastric pH value will exceed 3.0
Pharmacodynamics - median time when the pH was above 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 4.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
10 secondary outcomes
Safety and Tolerability: adverse event (AE) number and frequency
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)
Safety and Tolerability: serious adverse event (SAE) number and frequency
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)
Safety and Tolerability: volunteer complaints
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)
Safety and Tolerability: physical examination results
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)
Safety and Tolerability: vital signs
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)
Safety and Tolerability: 12-lead electrocardiogram (ECG)
Time frame: Screening, Day 9
Safety and Tolerability: clinical blood test
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis (microscopy)
Time frame: Screening, Day 2, Day 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antareit in people with Heartburn and Acid-dependent Diseases of the Gastrointestinal Tract, run by Valenta Pharm JSC at 2 sites 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 10 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
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?
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen (time frame: From 0 to 1 hour (Day 1 and Day 8)). The study lists 8 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 22 Jul 2024.