Randomised, crossover bioequivalence clinical trial of apixaban 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

CTIS2023-503557-35-00

Acronym

UECHUP-API/23-1

Enrollment

Registered

2023-06-02

Start date

2023-06-08

Completion date

2023-07-07

Last updated

2023-06-02

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

Conditions

thromboembolism

Brief summary

AUC0-t and Cmax of apixaban

Detailed description

AUC0-∞, Tmax and residual area of apixaban.

Interventions

DRUGEliquis 5 mg film-coated tablets

DRUGAPIXABAN

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
AUC0-t and Cmax of apixaban	—

Secondary

Measure	Time frame
AUC0-∞, Tmax and residual area of apixaban.	—

Countries

Spain

Outcome results

None listed

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