Bioeqivalence study of amlodipine valsartan 10/160 mg tablet
Not Applicable
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20220209053979N5
- Lead Sponsor
- Alborz Darou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Laboratory tests +/- 10% of normal interval
without any history of chronic sickness
Exclusion Criteria
Systolic blood pressure less than 90 and diastolic less than 60 mm Hg
Smoking more than 10 cigarette per day
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration time profile,. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.
- Secondary Outcome Measures
Name Time Method Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Pharmacokientic parameters are calculated by excel.