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.
• 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.