Bioequivalance study of Omeprazole 20mg
Not Applicable
- Conditions
- Bioequivalance Omeprazole 20mg.
- Registration Number
- IRCT20200513047423N2
- Lead Sponsor
- Sina Pishgam Darou Novin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy kidney
Observing BMI
Exclusion Criteria
Out of age ranges
No smoker
Unhealthy liver and kidney
Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increasing plasma concentration after administration of Omeprazple capsules till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of Omeprazole is between 1.5 and 2 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. Method of measurement: In this study, the variable is plasma concentration of Omeprazole. High performance liquid chromatography is used to determine the concentration of Omeprazole in plasma.
- Secondary Outcome Measures
Name Time Method