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 study about?

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.

1 Initial medical assessment

Your medical history will be reviewed and a physical examination will be performed to ensure you meet the study requirements.

Blood samples will be collected for laboratory tests including blood cell counts, coagulation tests, biochemistry panel, tests for hepatitis B surface antigen, hepatitis C antibodies, and HIV antibodies.

A urine sample will be collected for analysis.

Your vital signs such as blood pressure, heart rate, and temperature will be measured.

An electrocardiogram (a test that records the electrical activity of your heart) will be performed.

2 First treatment period

You will receive a single oral dose of one of the two formulations of ezetimibe/atorvastatin 10 mg/80 mg tablets.

The medication will be administered after an overnight fast, meaning you will not have eaten for several hours before taking the tablet.

Blood samples will be collected at specific time points after taking the medication to measure the levels of atorvastatin (a medication that lowers cholesterol) and ezetimibe (another medication that reduces cholesterol absorption) in your blood.

Blood sampling will continue for up to 72 hours after taking the medication to measure total ezetimibe levels.

3 Washout period

A period of time will pass between the first and second treatment periods to allow the medication from the first period to be completely eliminated from your body.

The duration of this washout period will be determined by the study protocol.

4 Second treatment period

You will receive a single oral dose of the other formulation of ezetimibe/atorvastatin 10 mg/80 mg that you did not receive in the first period.

This is a crossover design, meaning you will receive both formulations during the study, but in different periods.

The medication will again be administered after fasting.

Blood samples will be collected at the same time points as in the first period to measure drug levels in your blood.

Blood sampling will continue for up to 72 hours after taking the medication.

5 Final assessment

After completing both treatment periods, a final medical evaluation may be performed to assess your overall health status.

This marks the completion of your participation in the study.

Who Can Join the Study?

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 Study?

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

Where you can join this trial?

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Site Name	City	Country	Status
Hauwpymo Usmgznufeynga Dm Ln Pqqroocm	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	12.06.2023

Trial locations

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.

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 ID:

2023-504987-40-00

Protocol code:

N-EZEATO-23-277

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Study comparing two forms of ezetimibe and atorvastatin tablets in healthy volunteers to check if they work the same way in the body

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?