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New treatment option for Heartburn
Official title 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
What this study is testing
What is Antareit?
Antareit is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heartburn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);
You likely can't join if
- 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...
- Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune...
- Esophageal, gastric, and/or duodenal diseases based on EGC performed at screening and based on the medical history; a history of esophageal, gastric...
- Diseases/conditions which, in the opinion of the investigator, may affect the pH measurement results;
See the full eligibility criteria
- 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;
- 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.
- 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...
- 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
- Saint Petersburg, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia; Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.