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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513665-40-00
Enrollment
62
Registered
2024-06-13
Start date
2024-06-25
Completion date
2025-03-26
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable (submitted trial is a bioequivalence in healthy subjects)

Interventions

None listed

Sponsors

Adamed Pharma S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026