Bio equivalence study of Esomeprazole 40 mg
Not Applicable
- Conditions
- Bio equivalence Esomeprazole 40 mg.
- Registration Number
- IRCT20200513047423N3
- Lead Sponsor
- Sina pishgam daru novin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy Kidney
Observing BMI
Exclusion Criteria
Out of age ranges
smoking
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 esomeprazole 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 esomeprazole is between 1.5 and 2.5 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase.In the elimination phase (after Tmax)blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of esomeprazole. High performance liquid chromatography is used to determine the concentration of esomeprazole in plasma.
- Secondary Outcome Measures
Name Time Method