An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 Chewable Tablets and Riopan 800 mg Chewable Tablets in Healthy Volunteers

Valenta Pharm JSC3 sites in 1 country40 target enrollmentJuly 7, 2021

ConditionsHeartburn Acid-dependent Diseases of the Gastrointestinal Tract Symptomatic Treatment of Gastric and Duodenal Ulcers

InterventionsMagaldrate

DrugsMagaldrate

Overview

Phase: Not Applicable
Intervention: Magaldrate
Conditions: Heartburn
Sponsor: Valenta Pharm JSC
Enrollment: 40
Locations: 3
Primary Endpoint: Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 7, 2021

End Date

August 31, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Valenta Pharm JSC

Responsible Party

Sponsor

Eligibility Criteria

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);
•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.

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;
•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;
•Use of proton pump inhibitors 72 h prior to the Screening Visit;
•Use of (including use of a single dose) steroids and/or other ulcerogenic drug (e.g., nonsteriodal anti-inflammatory drugs \[NSAID\]) less than 4 weeks prior to the Screening Visit;

Arms & Interventions

TR-sequence (T-test drug, R-reference drug)

Group 1 (20 volunteers, TR sequence) will take 2 tablets of Antareit (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 tablets of Riopan (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 2

Intervention: Magaldrate

RT-sequence

Group 2 (20 volunteers, RT sequence) will take 2 tablets of Riopan (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 tablets of Antareit (magaldrate) 800 mg chewable tablets 2 h prior to food intake in Period 2

Intervention: Magaldrate

Outcomes

Primary Outcomes

Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen above the baseline

Time Frame: From 0 to 1 hour (Day 1 and Day 8)

Area under the pharmacodynamic pH-time curve adjusted to baseline (before drug intake)

Secondary Outcomes

Pharmacodynamics - рН minimum(From 0 to 1 hour (Day 1 and Day 8))
Pharmacodynamics - average pH value(From 0 to 1 hour (Day 1 and Day 8))
Safety and Tolerability: physical examination results - endocrine system(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(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(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))
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0(From 0 to 1 hour (Day 1 and Day 8))
Safety and Tolerability: physical examination results - cardiovascular system(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(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))
Pharmacodynamics - рН maximum(From 0 to 1 hour (Day 1 and Day 8))
Pharmacodynamics - time percentage 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 4.0(From 0 to 1 hour (Day 1 and Day 8))
Safety and Tolerability: physical examination results - digestive tract(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(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)(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))
Pharmacodynamics - median time when the pH was above 3.0(From 0 to 1 hour (Day 1 and Day 8))
Safety and Tolerability: adverse event (AE) number and frequency(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 - skin/visible mucous membranes(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(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: serious adverse event (SAE) number and frequency(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(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: clinical blood test - myelocytes(Screening, Day 2, Day 9)
Safety and Tolerability: vital signs - systolic blood pressure(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(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) - QRS complex(Screening, Day 9)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval(Screening, Day 9)
Safety and Tolerability: clinical blood test - hemoglobin(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - hematocrit(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - red blood cell count(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - platelet count(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - leukocyte count(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate(Screening, Day 2, Day 9)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval(Screening, Day 9)
Safety and Tolerability: clinical blood test - eosinophils(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - basophils(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - monocytes(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - lymphocytes(Screening, Day 2, Day 9)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate(Screening, Day 9)
Safety and Tolerability: clinical blood test - band neutrophils(Screening, Day 2, Day 9)
Safety and Tolerability: clinical blood test - segmented neutrophils(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - glucose(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - cholesterol(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - protein(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - bilirubin(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - creatinine(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - alkaline phosphatase(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - alanine transaminase(Screening, Day 2, Day 9)
Safety and Tolerability: blood chemistry - aspartate transaminase(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - specific gravity(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - color(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - transparency(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - pH(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - protein(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - glucose(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - red blood cells(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - white blood cells(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - epithelial cells(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - casts(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - mucus(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis - bacteria(Screening, Day 2, Day 9)
Safety and Tolerability: urinalysis (microscopy)(Screening, Day 2, Day 9)