Bioequivalence study of Rivaroxaban 20mg tablet
Not Applicable
- Conditions
- .
- Registration Number
- IRCT20200623047902N28
- Lead Sponsor
- Darou Darman Arang company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcohol and drug addiction
History of allergy to Rivaroxaban
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The plasma concentration of the drug. Timepoint: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48 and 72 h after drug admin. Method of measurement: Liquid Chromatography Mass-Mass.
- Secondary Outcome Measures
Name Time Method Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.