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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
A single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake
Llc "Certa Clinic"
Moscow, Russia
RECRUITINGLimited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia
RECRUITINGPharmacodynamics - AUCpH - Area under the curve potential of hydrogen
Area under the pharmacodynamic pH-time curve
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
PH - potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmaximum
maximum potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmin
minimum potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - average pH value
root mean square
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
During which the intragastric pH value will exceed 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 4.0
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
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
Time frame: 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 (SBP),diastolic blood pressure (DBP), heart rate (HR), body temperature
Time frame: 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)
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 legб V1-V6) taken while lying down: heart rate (beats per minute), 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), QRS complex (The QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram), corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Time frame: Screening, Day 9
Safety and Tolerability: clinical blood test
hemoglobin, hematocrit, Red blood cell count, Platelet count, Leukocyte count, erythrocyte sedimentation rate, Leukocyte formula (myelocytes, band neutrophils, segmented neutrophils, eosinophils, basophils, monocytes, lymphocytes)
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry
Glucose concentration, Total cholesterol concentration, Total protein concentration, Total bilirubin concentration, Creatinine concentration, Alkaline phosphatase activity, alanine transaminase and aspartate transaminase activity
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis
Relative density, Color, Transparency, pH, Protein concentration, Glucose concentration, Red blood cell content, White blood cell content, Epithelial cell content, Presence of casts, Presence of mucus, Presence of bacteria.
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present.
Time frame: Screening, Day 2, Day 9
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