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Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Antareit
Sponsored by
Valenta Pharm JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heartburn

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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 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 EGC 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; Regular use of any medicinal products, including prescription only and OTC drugs and dietary supplements within 2 weeks prior to the Screening Visit; Blood or plasma donation less than 3 months prior to the Screening Visit; Use of hormonal contraceptives (in women) less than 2 months prior to the Screening Visit; Pregnancy or breastfeeding; a positive pregnancy test for women of childbearing potential; Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study; Use of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine or 40 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol/drug dependence or drug abuse. Positive antibody blood test for HIV-1 and HIV-2, Treponema pallidum antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus antigen; Positive urine test for narcotic substances or strong drugs; Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test; Deviated septum/nasal obstruction preventing the placement of the pH probe; Medical history of chronic constipation; Medical history of severe maxillofacial injuries; Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol; Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime; Positive SARS-CoV-2 (COVID-19) rapid test; Other circumstances which in the opinion of the investigator prevent a volunteer from being included in the study or may result in premature drop-out from the study. Withdrawal criteria: The volunteer's refusal to further participate in the study; Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.); Taking prohibited therapy; Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer, including severe AEs; Volunteers selected to participate in the study in violation of the inclusion/non-inclusion criteria; Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.); Missing a dose of the study drug/comparator drug during any period of the study for any reason; Positive urine test for narcotics and powerful drugs; Positive breath alcohol vapor test or alcohol in saliva; Positive pregnancy test in women; Positive test for COVID-19; The occurrence in the course of the study of other reasons that prevent the study according to the protocol.

Sites / Locations

  • Llc "Certa Clinic"
  • Limited Liability Company "Research Center Eco-Safety"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TR-sequence

RT-sequence

Arm Description

Group 1 (25 volunteers, TR sequence) will take 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 1 and 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 2

Group 2 (25 volunteers, RT sequence) will take 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 2

Outcomes

Primary Outcome Measures

Pharmacodynamics - AUCpH
Area under the pharmacodynamic pH-time curve
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
Pharmacodynamics- рНmax
maximum рН
Pharmacodynamics- рНmin
minimum рН
Pharmacodynamics - average pH value
root mean square
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
During which the intragastric pH value will exceed 3.0
Pharmacodynamics - median time when the pH was above 3.0
Pharmacodynamics - median time when the pH was above 4.0

Secondary Outcome Measures

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
Safety and Tolerability: vital signs
systolic blood pressure (SBP),diastolic blood pressure (DBP), heart rate (HR), body temperature
Safety and Tolerability: 12-lead electrocardiogram (ECG)
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute), PQ interval, QRS complex, corrected QT interval
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)
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
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.
Safety and Tolerability: urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present.

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Valenta Pharm JSC
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1. Study Identification

Unique Protocol Identification Number
NCT06098742
Brief Title
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
July 20, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valenta Pharm JSC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract, Symptomatic Treatment of Gastric and Duodenal Ulcers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TR-sequence
Arm Type
Experimental
Arm Description
Group 1 (25 volunteers, TR sequence) will take 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 1 and 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 2
Arm Title
RT-sequence
Arm Type
Experimental
Arm Description
Group 2 (25 volunteers, RT sequence) will take 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 2
Intervention Type
Drug
Intervention Name(s)
Antareit
Intervention Description
A single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake
Primary Outcome Measure Information:
Title
Pharmacodynamics - AUCpH
Description
Area under the pharmacodynamic pH-time curve
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics- рНmax
Description
maximum рН
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics- рНmin
Description
minimum рН
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics - average pH value
Description
root mean square
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
Description
During which the intragastric pH value will exceed 3.0
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics - median time when the pH was above 3.0
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Title
Pharmacodynamics - median time when the pH was above 4.0
Time Frame
From 0 to 1 hour (Day 1 and Day 8)
Secondary Outcome Measure Information:
Title
Safety and Tolerability: adverse event (AE) number and frequency
Description
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)
Title
Safety and Tolerability: serious adverse event (SAE) number and frequency
Description
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)
Title
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)
Title
Safety and Tolerability: physical examination results
Description
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)
Title
Safety and Tolerability: vital signs
Description
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)
Title
Safety and Tolerability: 12-lead electrocardiogram (ECG)
Description
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute), PQ interval, QRS complex, corrected QT interval
Time Frame
Screening, Day 9
Title
Safety and Tolerability: clinical blood test
Description
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
Title
Safety and Tolerability: blood chemistry
Description
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
Title
Safety and Tolerability: urinalysis
Description
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
Title
Safety and Tolerability: urinalysis (microscopy)
Description
Microscopy of urine sediment is performed if it is present.
Time Frame
Screening, Day 2, Day 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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 EGC 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; Regular use of any medicinal products, including prescription only and OTC drugs and dietary supplements within 2 weeks prior to the Screening Visit; Blood or plasma donation less than 3 months prior to the Screening Visit; Use of hormonal contraceptives (in women) less than 2 months prior to the Screening Visit; Pregnancy or breastfeeding; a positive pregnancy test for women of childbearing potential; Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study; Use of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine or 40 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol/drug dependence or drug abuse. Positive antibody blood test for HIV-1 and HIV-2, Treponema pallidum antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus antigen; Positive urine test for narcotic substances or strong drugs; Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test; Deviated septum/nasal obstruction preventing the placement of the pH probe; Medical history of chronic constipation; Medical history of severe maxillofacial injuries; Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol; Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime; Positive SARS-CoV-2 (COVID-19) rapid test; Other circumstances which in the opinion of the investigator prevent a volunteer from being included in the study or may result in premature drop-out from the study. Withdrawal criteria: The volunteer's refusal to further participate in the study; Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.); Taking prohibited therapy; Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer, including severe AEs; Volunteers selected to participate in the study in violation of the inclusion/non-inclusion criteria; Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.); Missing a dose of the study drug/comparator drug during any period of the study for any reason; Positive urine test for narcotics and powerful drugs; Positive breath alcohol vapor test or alcohol in saliva; Positive pregnancy test in women; Positive test for COVID-19; The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
Facility Information:
Facility Name
Llc "Certa Clinic"
City
Moscow
ZIP/Postal Code
109235
Country
Russian Federation
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander S Goncharov, MD
Phone
+7 (495) 121 07 05
Email
info@certa-clinic.ru
Facility Name
Limited Liability Company "Research Center Eco-Safety"
City
Saint Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Zakharov, MD
Phone
+7 921 950 29 91
Email
konstantin.zakharov@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers

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