Actively Recruiting
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
Led by Valenta Pharm JSC · Updated on 2024-07-22
50
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial involves healthy volunteers aged 18 to 45 years to compare the pharmacodynamic effects and bioequivalence of two drugs: Antareit 800 mg/10 ml oral suspension and Riopan 800 mg chewable tablets. The study focuses on measuring how these drugs affect stomach acidity by monitoring various pH-related parameters over a short period. Participants are randomly assigned to one of two groups in a crossover design. One group takes Antareit first and then Riopan, while the other group follows the reverse order. In each period, volunteers take two sachets of Antareit or two tablets of Riopan two hours before eating. This design allows comparison of the drugs' effects within the same individuals. During the study, volunteers undergo monitoring including hourly pH measurements of stomach acidity, physical examinations, vital signs, ECGs, blood tests, and urinalysis from screening through day 15. Researchers will assess pharmacodynamic measures such as area under the pH curve and time with pH above certain thresholds. Safety and tolerability are closely observed through reports of adverse events and clinical assessments throughout the trial period.
CONDITIONS
Brief Title
Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by a healthy volunteer before any study procedures
- Healthy male and female Caucasian volunteers aged 18 to 45 years inclusive
- Verified healthy status with no abnormal clinical, laboratory, or instrumental test findings
- Stomach pH between 1 and 3 during a 1-hour measurement after fasting at screening
- Blood pressure between 100 to 139 mm Hg systolic and 60 to 89 mm Hg diastolic
- Heart rate between 60 to 90 beats per minute
- Body mass index between 18.5 and 30 kg/m2; weight at least 55 kg for men and 45 kg for women
- Non-smokers or those who quit smoking more than 6 months before screening
- Agreement to use adequate contraception during the study and for 30 days after; negative pregnancy test for women of reproductive potential
- Adequate behavior and coherent speech
You will not qualify if you...
- History of allergy or drug intolerance to study drugs or anesthetics used during procedures
- Chronic diseases affecting various body systems
- Esophageal, gastric, or duodenal diseases or previous related surgeries
- Conditions affecting stomach pH measurement results
- Recent acute infections within 4 weeks prior to screening
- Use of antacids within 24 hours, proton pump inhibitors within 72 hours, steroids or ulcerogenic drugs within 4 weeks before screening
- Regular use of any medications or supplements within 2 weeks before screening
- Blood or plasma donation less than 3 months before screening
- Use of hormonal contraceptives less than 2 months before screening
- Pregnancy or breastfeeding; positive pregnancy test
- Participation in another clinical trial within 3 months or simultaneous participation
- Excessive alcohol use or history of alcohol/drug dependence
- Positive tests for HIV, syphilis, hepatitis B or C, narcotics, or alcohol
- Nasal obstruction preventing placement of pH probe
- Medical history of chronic constipation or severe facial injuries
- Expected hospitalization during the study except per protocol
- Inability to comply with protocol or dietary/activity restrictions
- Positive COVID-19 test
- Other investigator-determined reasons preventing study participation or causing premature withdrawal
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 15 days
Participants receive a single dose of either Antareit oral suspension or Riopan chewable tablets 2 hours prior to food intake in each of two study periods as part of a crossover design.
Multiple visits including dosing on Day 1 and Day 8 with assessments
Duration - Up to 15 days
Participants are monitored for safety and tolerability through physical exams, vital signs, ECG, blood tests, and urinalysis until Day 15 or early termination.
Visits on Days 0 to 2, Day 7 to 9, Day 15 or early termination visit
Trial Site Locations
Total: 2 locations
1
Llc "Certa Clinic"
Moscow, Russia, 109235
Actively Recruiting
2
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia, 196143
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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