Bioequivalence study of ezetimibe and atorvastatin tablets versus film‑coated tablets in healthy volunteers

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What is this study about?

The study examines a cholesterol‑lowering medication that combines ezetimibe and atorvastatin. Two versions are compared: a standard tablet and a film‑coated tablet. This medication is normally taken by mouth to help lower high cholesterol, a condition that can increase the risk of heart problems.

The purpose of the study is to evaluate the relative bioavailability of the test formulation compared with the commercial reference and to demonstrate their bioequivalence according to health‑authority criteria. Healthy adults will receive a single dose of one formulation after an overnight fast, then, after a short break, will receive the other formulation. Blood samples will be taken over several hours to measure how much of the drug reaches the bloodstream, looking at total exposure (AUC), the highest concentration reached (Cmax) and the time it takes to reach that peak (Tmax).

Volunteers will be monitored for any side effects while staying in a comfortable setting, and the study will be completed in a short period of time with only a few clinic visits. No disease is being treated in the participants; the goal is simply to confirm that the two tablet types behave the same way in the body.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hryuisbb Ufecurjbkeqtl Dd Lz Pojscmgp Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
30.08.2023

Trial locations

Trial ID:
2023-506559-10-00
Protocol code:
N-EZEATO-23-280
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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