HeartburnNCT06552624
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers
A study testing Magaldrate in people with Heartburn and Acid-dependent Diseases of the Gastrointestinal Tract, run by Valenta Pharm JSC at 3 sites in Russia.
Trial 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. 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?
- Magaldrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesRussia
- Study dates
- 7 Jul 2021to 31 Aug 2022
- 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 substance 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 EGD 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;
- 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 strong drugs;
- Positive breath alcohol vapor test or alcohol in saliva;
- Positive pregnancy test in women;
- The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Llc "Certa Clinic"
Moscow, 109235
Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
Saint Petersburg, 195271
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
About this study
Official title: An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers
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.
- Conditions
- Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers
- Being tested
- Magaldrate
- 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.
MagaldrateDrug
Also called Antareit (T)
A dose of T drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day
MagaldrateDrug
Also called Riopan (R)
A dose of R drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| TR-sequence (T-test drug, R-reference drug) | Experimental | 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 Receives: Drug: Magaldrate |
| RT-sequence | Experimental | 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 Receives: Drug: Magaldrate |
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 above the baseline
Area under the pharmacodynamic pH-time curve adjusted to baseline (before drug intake)
Measured: From 0 to 1 hour (Day 1 and Day 8)
Secondary outcomes (60)
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 - рН maximum
Maximum potential of hydrogen
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - рН minimum
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
Time 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
Time during which the intragastric pH value will be above 3.0
Measured: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 4.0
Time during which the intragastric pH value will be above 4.0
Measured: From 0 to 1 hour (Day 1 and Day 8)
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
Description of complaints, recieved from volunteer
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 - cardiovascular system
An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)
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: 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)
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: 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)
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: 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)
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: 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)
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: 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)
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: 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)
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: 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)
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
Systolic blood pressure (SBP, mmHg)
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 - diastolic blood pressure
Diastolic blood pressure (DBP, mmHg)
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 - heart rate
Heart rate (HR, bpm)
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 - body temperature (Celsius temperature scale)
Body temperature (Celsius temperature scale)
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) - 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)
Measured: Screening, Day 9
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)
Measured: Screening, Day 9
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)
Measured: Screening, Day 9
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)
Measured: Screening, Day 9
Safety and Tolerability: clinical blood test - hemoglobin
Hemoglobin (g/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - hematocrit
hematocrit (%)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (m/h)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (segmented neutrophils, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - eosinophils
Leukocyte formula (eosinophils, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - protein
Total protein concentration (g/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - epithelial cells
Epithelial cell content (number in sight)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - casts
Presence of casts (Yes/No)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - mucus
Presence of mucus (Yes/No)
Measured: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis - bacteria
Presence of bacteria (Yes/No)
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 posted14 Aug 2024
- Study start7 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552624
- Sponsor's protocol ID
- ANT-05-02-2021
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 14 Aug 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 14 Aug 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 Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06552624
- Acronym / sponsor ID
- ANT-05-02-2021
- Conditions
- Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Aug 2024 (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 chewable tablets 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: MagaldrateGroup 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 |
| RT-sequence | Experimental | Drug: MagaldrateGroup 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 |
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 (37 listed)
- A history of allergy;
- History of drug intolerance to the active substance 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 EGD 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 |
|---|---|---|
| MagaldrateAlso: Antareit (T)A dose of T drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day | Drug | RT-sequence, TR-sequence (T-test drug, R-reference drug) |
| MagaldrateAlso: Riopan (R)A dose of R drug in one of 2 periods of the study 2 h prior to food intake, 3 times per day | Drug | RT-sequence, TR-sequence (T-test drug, R-reference drug) |
Primary outcome
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Area under the pharmacodynamic pH-time curve adjusted to baseline (before drug intake)
60 secondary outcomes
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)
Pharmacodynamics - рН maximum
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - рН minimum
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - average pH value
Time frame: From 0 to 1 hour (Day 1 and Day 8)
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)
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)
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 - cardiovascular system
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: physical examination results - respiratory system
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: physical examination results - digestive tract
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: physical examination results - endocrine system
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: physical examination results - musculoskeletal system
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: physical examination results - nervous system
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: physical examination results - sensory systems
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: physical examination results - skin/visible mucous membranes
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 - systolic blood pressure
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 - diastolic blood pressure
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 - heart rate
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 - 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)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time frame: Screening, Day 9
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Time frame: Screening, Day 9
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Time frame: Screening, Day 9
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
Time frame: Screening, Day 9
Safety and Tolerability: clinical blood test - hemoglobin
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - hematocrit
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - red blood cell count
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - platelet count
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - leukocyte count
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - myelocytes
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - band neutrophils
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - segmented neutrophils
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - eosinophils
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - basophils
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - monocytes
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: clinical blood test - lymphocytes
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry - glucose
Time frame: Screening, Day 2, Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magaldrate in people with Heartburn and Acid-dependent Diseases of the Gastrointestinal Tract, run by Valenta Pharm JSC at 3 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 37 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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline (time frame: From 0 to 1 hour (Day 1 and Day 8)). 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 14 Aug 2024.