Randomised, crossover bioequivalence clinical trial of apixabán 5 mg film coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503970-19-00

Acronym

N-API-23-276

Enrollment

Registered

2023-03-27

Start date

2023-03-31

Completion date

2023-04-28

Last updated

2023-03-27

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

Conditions

Healthy volunteers

Brief summary

AUC0-t, Cmax

Detailed description

AUC0-∞, Tmax

Interventions

DRUGEliquis 5 mg film-coated tablets

DRUGApixabán Normon 5 mg comprimidos recubiertos con película

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
AUC0-t, Cmax	—

Secondary

Measure	Time frame
AUC0-∞, Tmax	—

Countries

Spain

Outcome results

None listed

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