Randomised, crossover bioequivalence clinical trial of rosuvastatin/ezetimibe 20 mg/ 10 mg film-coated tablets versus rosuvastatin/ezetimibe 20 mg/ 10 mg hard capsules, 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

CTIS2022-501862-24-00

Acronym

N-ROSEZE-22-274

Enrollment

Registered

2022-11-22

Start date

2022-11-25

Completion date

2023-01-27

Last updated

2022-11-22

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

Conditions

Healthy volunteers

Brief summary

Rosuvastatine AUC0-t and Cmax., Total ezetimibe: AUC0-72 and Cmax.

Detailed description

Rosuvastatine: AUC0-∞, Tmax and residual area., Total Ezetimibe: Tmax.

Interventions

DRUGRosuvastatina/Ezetimiba Normon 20 mg/10 mg comprimidos recubiertos con película

DRUGLipocomb 20 mg/10 mg cápsulas duras

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Rosuvastatine AUC0-t and Cmax., Total ezetimibe: AUC0-72 and Cmax.	—

Secondary

Measure	Time frame
Rosuvastatine: AUC0-∞, Tmax and residual area., Total Ezetimibe: Tmax.	—

Countries

Spain

Outcome results

None listed

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