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

NCT06098742 | Recruiting

• 1 other identifier: ANT-05-01-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen

  Area under the pharmacodynamic pH-time curve

  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

  From 0 to 1 hour (Day 1 and Day 8)

• Pharmacodynamics- рНmaximum

  maximum potential of hydrogen

  From 0 to 1 hour (Day 1 and Day 8)

• Pharmacodynamics- рНmin

  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

  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

  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)

Secondary Outcomes (10)

• 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: 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: physical examination results

  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

  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)

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Antareit

RT-sequence

EXPERIMENTAL

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

Drug: Antareit

Interventions

Antareit DRUG

A single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 (Over-the-counter) 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;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (2)

Llc "Certa Clinic"

Moscow, 109235, Russia

RECRUITING

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

RECRUITING

MeSH Terms

Conditions

Heartburn; Duodenal Ulcer

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: April 25, 2024
• Primary Completion: October 20, 2024
• Study Completion: September 20, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

RU (2)