A bioequivalence study of Rivaroxaban 20 mg tab compared to Xarelto 20 mg tab manufactured by Bayer in 24 healthy volunteers under fasting conditio
Not Applicable
- Conditions
- Investigation of bioequivalence of Rivaroxaban tablets manufactured by Pars Daroo company in comparison to the xarelto made by Bayer company.
- Registration Number
- IRCT20220209053979N1
- Lead Sponsor
- Pars Darou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Have no history of heart, liver, kidney, lung, coagulation disorders
They have not taken any medication at least one month before starting the study
Exclusion Criteria
Systolic blood pressure above 13 and below 10 and diastolic blood pressure below 6 and above 85 mm Hg
heart rate more than 90 or less than 60 beats per minute
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of the drug obtained from rivaroxaban tablets made by Pars Darou Company and Bayer Company. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32 hour. Method of measurement: LCMSMS.
- Secondary Outcome Measures
Name Time Method