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
Not yet recruiting
- 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Rivaroxaban in anticoagulation and how do they compare to other Factor Xa inhibitors?
How does the bioavailability of Rivaroxaban tablets from Pars Daroo compare to Bayer's formulation in healthy volunteers under fasting conditions?
What biomarkers are associated with response to Rivaroxaban in patients with venous thromboembolism or atrial fibrillation?
What are the known adverse events of Rivaroxaban compared to standard anticoagulants like Warfarin and how are they managed?
How does the bioequivalence of generic Rivaroxaban formulations compare to branded Xarelto in clinical trials?