Randomised, crossover bioequivalence clinical trial of ezetimibe/atorvastatin 10 mg/80 mg tablets versus ezetimibe/atorvastatin 10 mg/80 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

CTIS2023-504987-40-00

Acronym

N-EZEATO-23-277

Enrollment

Registered

2023-06-23

Start date

2023-06-26

Completion date

2023-07-19

Last updated

2023-06-23

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

Conditions

Healthy volunteers

Brief summary

Atorvastatin AUC0-t, Atorvastatin Cmax, Total ezetimibe AUC0-72, Total ezetimibe Cmax

Detailed description

Atorvastatin AUC0-∞, Atorvastatin Tmax, Atorvastatin residual area, Total ezetimibe Tmax

Interventions

DRUGEzetimiba/Atorvastatina Normogen 10 mg/80 mg comprimidos

DRUGATOZET 10 mg/80 mg comprimidos recubiertos con película

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Atorvastatin AUC0-t, Atorvastatin Cmax, Total ezetimibe AUC0-72, Total ezetimibe Cmax	—

Secondary

Measure	Time frame
Atorvastatin AUC0-∞, Atorvastatin Tmax, Atorvastatin residual area, Total ezetimibe Tmax	—

Countries

Spain

Outcome results

None listed

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