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.
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;
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;
Crossover
Antareit
DrugA single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen
Area under the pharmacodynamic pH-time curve
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
PH - potential of hydrogen
Pharmacodynamics- рНmaximum
maximum potential of hydrogen
Pharmacodynamics- рНmin
minimum potential of hydrogen
Safety and Tolerability: adverse event (AE) number and frequency
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Safety and Tolerability: serious adverse event (SAE) number and frequency
Number and frequency of serious AEs (SAEs)
Safety and Tolerability: volunteer complaints
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
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