Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers
NCT Number: NCT06552624
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heartburn|Acid-dependent Diseases of the Gastrointestinal Tract|Symptomatic Treatment of Gastric and Duodenal Ulcers
Interventions: DRUG: Magaldrate|DRUG: Magaldrate
Sponsor: Valenta Pharm JSC
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-07-07
Completion Date: 2022-08-31
Locations: Llc "Certa Clinic", Moscow, 109235, Russian Federation|Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg, Saint Petersburg, 195271, Russian Federation|Limited Liability Company "Research Center Eco-Safety", Saint Petersburg, 196143, Russian Federation

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.

Primary Outcome Measures: 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), From 0 to 1 hour (Day 1 and Day 8)
Secondary Outcome Measures: Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0, PH - potential of hydrogen, From 0 to 1 hour (Day 1 and Day 8)|Pharmacodynamics - рН maximum, Maximum potential of hydrogen, From 0 to 1 hour (Day 1 and Day 8)|Pharmacodynamics - рН minimum, Minimum potential of hydrogen, From 0 to 1 hour (Day 1 and Day 8)|Pharmacodynamics - average pH value, Root mean square, 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, 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, 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, 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), 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), 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, 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), Screening, Day 9|Safety and Tolerability: clinical blood test - hemoglobin, Hemoglobin (g/L), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - hematocrit, hematocrit (%), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - red blood cell count, Red blood cell count (cells/L), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - platelet count, Platelet count (cells/L), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - leukocyte count, Leukocyte count (cells/L), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate, Erythrocyte sedimentation rate (m/h), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - myelocytes, Leukocyte formula (myelocytes, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - band neutrophils, Leukocyte formula (band neutrophils, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - segmented neutrophils, Leukocyte formula (segmented neutrophils, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - eosinophils, Leukocyte formula (eosinophils, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - basophils, Leukocyte formula (basophils, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - monocytes, Leukocyte formula (monocytes, %), Screening, Day 2, Day 9|Safety and Tolerability: clinical blood test - lymphocytes, Leukocyte formula (lymphocytes, %), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - glucose, Glucose concentration (mmol/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - cholesterol, Total cholesterol concentration (mmol/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - protein, Total protein concentration (g/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - bilirubin, Total bilirubin concentration (micromol/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - creatinine, Creatinine concentration (micromol/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - alkaline phosphatase, Alkaline phosphatase activity (U/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - alanine transaminase, Alanine transaminase activity (U/L), Screening, Day 2, Day 9|Safety and Tolerability: blood chemistry - aspartate transaminase, Aspartate transaminase activity (U/L), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - specific gravity, Specific gravity of the urine, Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - color, Color of the urine, Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - transparency, Transparency of the urine, Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - pH, pH of the urine, Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - protein, Protein concentration (g/L), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - glucose, Glucose concentration (mmol/L), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - red blood cells, Red blood cell content (number in sight), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - white blood cells, White blood cell content (number in sight), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - epithelial cells, Epithelial cell content (number in sight), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - casts, Presence of casts (Yes/No), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - mucus, Presence of mucus (Yes/No), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis - bacteria, Presence of bacteria (Yes/No), Screening, Day 2, Day 9|Safety and Tolerability: urinalysis (microscopy), Microscopy of urine sediment is performed if it is present, Screening, Day 2, Day 9