Actively Recruiting
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
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 to participate in the study
- Healthy males and females aged 18 to 45 years
- Confirmed healthy status by clinical, laboratory, and instrumental tests
- Stomach pH between 1 and 3 during screening pH-metry
- Blood pressure between 100-139 mm Hg systolic and 60-89 mm Hg diastolic
- Heart rate between 60 and 90 beats per minute
- Body mass index between 18.5 and 30 kg/m2 with minimum weight 55 kg for men and 45 kg for women
- Non-smokers or those who quit smoking more than 6 months ago
- Agreement to use contraception and negative pregnancy test for women of childbearing potential
- Adequate behavior and coherent speech
You will not qualify if you...
- History of allergies or drug intolerance to study drugs or related anesthetics
- Chronic diseases affecting multiple systems including circulatory, respiratory, nervous, endocrine, gastrointestinal, and immune
- Esophageal, gastric, or duodenal diseases or surgeries
- Conditions affecting pH measurement results
- Acute infections within 4 weeks prior to screening
- Use of antacids or H2 antagonists within 24 hours prior to screening
- Use of proton pump inhibitors within 72 hours prior to screening
- Use of steroids or ulcerogenic drugs within 4 weeks prior to screening
- Regular use of medications or supplements within 2 weeks prior to screening
- Blood or plasma donation within 3 months prior to screening
- Use of hormonal contraceptives within 2 months prior to screening
- Pregnancy or breastfeeding
- Participation in another clinical trial within 3 months
- Excessive alcohol use or history of alcohol/drug dependence
- Positive tests for HIV, hepatitis, syphilis, narcotics, alcohol
- Nasal obstruction preventing pH probe placement
- History of chronic constipation or severe maxillofacial injuries
- Expected hospitalization during the study except for protocol-related
- Inability to comply with study procedures or diet
- Positive COVID-19 rapid test
- Other investigator-determined reasons preventing participation or causing dropout
AI-Screening
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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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