Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg Chewable Tablets… (NCT06552624) | Clinical Trial Compass
CompletedNot Applicable
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers
Russia40 participantsStarted 2021-07-07
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion 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);
Exclusion criteria
✕. 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;
What they're measuring
1
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline
✕. 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;
✕. 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;