Gastric ulcer. Gastric ulcer
Conditions
Interventions
Intervention 1: Intervention group 1: Omeprazole 20 mg Capsule , produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-
Sponsors
ACtover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) should be between 20-45 years old. subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2) Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Subjects with known allergy to the products tested. Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination. Chronic or acute diseases of the digestive system, such as diseases related to the esophagus, gastritis, peptic ulcer, intestinal inflammation, bleeding in the digestive tract, or digestive system surgery during the last three years. Having problems with vascular system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic system. Performing surgery within 4 weeks before drug administration or at the time of clinical study. Smoking more than 10 cigarettes per day, losing more than 500 ml of blood in less than 7 days. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 3, 4, 6, 8, 10, 12 and 24 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehzad Montaha Sangari
Noor Research & Development Institute
Outcome results
None listed