Gastric and duodenal ulcer disease
Conditions
Interventions
2:concentration of the drug in blood plasma
Sponsors
VIAL LLC
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Men aged 18 to 45 years old; 2. Written informed consent to participate in the study; 3. Status: "healthy" upon screening: no pathology of the gastrointestinal tract, liver, kidney, cardiovascular and endocrine system, central nervous system (previously performed standard clinical lab tests did not reveal the presence of any disease); 4. The negative results of blood tests for HIV, syphilis and hepatitis (HBV and HCV); 5. Body mass index is 18, 5-30 kg / m2; 6. A negative urine test for drug and substance abuse; 7. A negative test for alcohol in exhaled air; 8. A volunteer is able to understand the requirements of the study, as well as to agree to any restrictions imposed in the course of the study, and agrees to comly eith the schedule of visits to with stand the required investigations.
Exclusion criteria
Exclusion criteria: 1. The presence of clinically significant allergic reactions in anamnesis; 2. Drug intolerance; 3. Hypersensitivity to the investigational drug or any of its excipients; 4. Known hypersensitivity to benzimidazole; 5. Lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption; 6. Congenital fructose intolerance, sucrase-isomaltase defficiency; 7. Chronic diseases of the cardiovascular, nervous and endocrine systems, as well as diseases of the gastrointestinal tract (including ulcers, bleeding in medical history), liver, kidney, hematopoietic and immune systems, mental illness; 8. Systolic blood pressure less than 95 mm.Hg. or above 139 mmHg; diastolic blood pressure less than 65 mmHg or above 89 mmHg; heart rate less than 60 beats/min, or greater than 90 beats/min; 9. Abnormalities in clinical, instrumental and laboratory parameters detected on screening; 10. Mental, physical or other reasons that do not allow to adequately assess self behavior by a volunteer to properly fulfill the requirements of the study Protocol; 11. Previous surgery on abdominal organs, which may have a significant effect on the absorption or metabolism of the drug (except appendectomy); 12. Acute infectious diseases 4 weeks and less before the start of the study; 13. Special diet (e.g. vegetarian) or lifestyle (including night shifts and extreme physical exertion, such as weight lifting) that may impede the course of the trial; 14. Regular use of medicines in 2 weeks and less before the start of the study; 15. Use of medications with marked impact on hemodynamics, liver function, etc. (such as barbiturates, omeprazole, cimetidine, hormonal contraceptives, etc.), 2 months and less prior to the study inception; 16. Blood donation (450 ml blood or plasma, and more) 2 months and less prior to the study inception; 17. Volunteer's participation in the Phase I clinical trial 3 months and less prior to the study initiation; 19. Consuming more than 10 units of alcohol (one unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of hard liquors) a week, or alcoholism in anamnesis, drug addiction, substance abuse and alcohol abuse, use of caffeine-containing substances and xanthine 72 hours and less before the study, and throughout its duration; 20. Smoking more than 10 cigarettes a day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Countries
Russia
Contacts
Public ContactSotnikov I.E
Outcome results
None listed