Randomized, open-label, single dose, two-period, two-treatment, cross-over bioequivalence study comparing test product Rivaroxaban/Acetylsalicylic acid, tablet, 2.5 mg/50 mg (given as two tablets) to reference product Xarelto 2.5 mg film-coated tablets (given as two tablets) and Aspirin® N 100 mg tablet in healthy male and female subjects under fasting conditions.
Phase 1
- Conditions
- not applicable (submitted trial is a bioequivalence in healthy subjects)MedDRA version: 20.0Level: HLGTClassification code: 10014523Term: Embolism and thrombosis Class: 10047065Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-513665-40-00
- Lead Sponsor
- Adamed Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method