Hospital Universitario De La Princesa
Madrid, Spain
Not recruiting
Study comparing two forms of ezetimibe and atorvastatin tablets in healthy volunteers to check if they work the same way in the body
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is studying two different tablet formulations containing ezetimibe and atorvastatin in healthy volunteers. These are medications commonly used to lower cholesterol levels in the blood. The study will compare a test formulation of ezetimibe/atorvastatin tablets with a commercially available film-coated tablet formulation of the same combination, both containing 10 mg of ezetimibe and 80 mg of atorvastatin. The purpose of the study is to evaluate whether the test formulation releases the medications into the body at the same rate and to the same extent as the commercial formulation, and to demonstrate that they are equivalent according to health authorities' standards.
This is a crossover study, which means that participants will receive both formulations at different times during the trial. Participants will take a single dose of each formulation by mouth under fasting conditions, meaning they will not have eaten before taking the medication. Between receiving the two different formulations, there will be a period of time to allow the first medication to be completely eliminated from the body before the second one is given. During the study, blood samples will be collected at various times to measure the levels of atorvastatin and ezetimibe in the bloodstream.
The study will measure how much of each medication appears in the blood over time and how quickly the maximum concentration is reached. These measurements will help determine if the test formulation works in the same way as the commercial formulation already available on the market. The trial involves healthy volunteers between 18 and 55 years of age who have no significant medical conditions and whose laboratory tests and physical examinations show no clinically important abnormalities.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- You must be willing to participate in the study after receiving full information about its design, objectives, and possible risks, and you must sign a written consent form showing you agree to take part and understand you can leave the study at any time
- You must be between 18 and 55 years old
- You must not have any significant physical or mental health conditions that could affect the study
- Your medical history, which is a record of your past health and illnesses, and physical examination, which is when a doctor checks your body, must not show any significant problems
- Your blood tests must be normal, including tests for haematology which checks your blood cells, coagulation which checks how your blood clots, biochemistry which checks chemicals in your blood, serology which checks for infections like Hepatitis B, Hepatitis C, and HIV, and urinalysis which checks your urine
- Your vital signs, which include measurements like blood pressure, heart rate, and temperature, and your electrocardiogram, which is a test that records the electrical activity of your heart, must not show any significant problems
Who cannot join the trial?
9 criteria
- The study does not list specific exclusion criteria in the provided information
- This study involves healthy volunteers, which means people who do not have the medical conditions being studied
- General exclusion criteria for studies with healthy volunteers typically include having any serious health problems or taking medications that could affect the study results
- Women who are pregnant, which means carrying a baby, or breastfeeding, which means nursing a baby, are usually not allowed to participate
- People with known allergies, which means bad reactions, to ezetimibe, a medicine that lowers cholesterol in the blood, or atorvastatin, another medicine that lowers cholesterol, cannot participate
- People with liver problems or kidney problems are usually excluded because these organs help process medications in the body
- People who have recently participated in other clinical studies may not be allowed to join
- People who use tobacco products or drink alcohol regularly may be excluded
- People who cannot follow the study rules or attend all required visits cannot participate
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Investigated drugs
Ezetimibe/Atorvastatin is a combination medication that contains two medicines used to lower cholesterol levels in the blood. Ezetimibe works by reducing the amount of cholesterol absorbed from food in your intestines, while atorvastatin belongs to a group of medicines called statins that help reduce the production of cholesterol in your liver. This medication is commonly prescribed to help lower bad cholesterol and reduce the risk of heart disease in people who need additional cholesterol control beyond diet and exercise alone.
What is already known about the treatment
Ezetimibe/Atorvastatin 10 mg/80 mg – This medication is a combination tablet taken by mouth that contains two different cholesterol-lowering drugs working together to reduce high cholesterol levels in the blood. Ezetimibe works by blocking the absorption of cholesterol from food in the intestines, while atorvastatin belongs to a group of medicines called statins that reduce the production of cholesterol in the liver by blocking a specific enzyme needed for cholesterol formation. This combination medication is currently approved and widely used in medical practice for treating patients who need stronger cholesterol control, particularly those at high risk for heart disease and stroke. The clinical trial mentioned is testing whether a new tablet formulation works the same way in the body as the existing commercial version to ensure patients receive the same therapeutic benefit.
Investigated diseases
Healthy volunteers – This study involves healthy volunteers, which means participants who do not have any diseases or medical conditions being studied. Healthy volunteers are individuals who are free from significant medical problems and meet specific health criteria set by the research study. They participate in clinical trials to help researchers understand how medications work in people without the disease the drug is intended to treat. These volunteers typically undergo screening to confirm they are in good health before joining the study. Their participation helps establish baseline data about how a medication behaves in the body under normal conditions. This information is essential for comparing how the same medication might work differently in people who have specific health conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504987-40-00Protocol codeN-EZEATO-23-277Estimated enrolment14 patientsSponsorLaboratorios Normon S.A.
sourced from the EU Clinical Trials Register and site verification
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