A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing apixaban 5 mg hard capsules (PG412 [Celon Pharma]) vs apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511526-31-00

Acronym

01API2024

Enrollment

Registered

2024-08-13

Start date

2024-08-20

Completion date

2024-10-21

Last updated

2024-08-13

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

Conditions

and prevention of recurrent DVT and PE in adults., Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), with one or more risk factors

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Countries

Poland

Outcome results