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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You arrive at the study site after receiving a written invitation. you read and sign an information form that explains the purpose of the trial and your rights as a participant.

    A brief health check is performed to confirm that you are a healthy volunteer and meet the study criteria. you are instructed to fast (no food or drink except water) for at least 8 hours before the first dosing day.

  2. Step 2

    First dosing period

    On the scheduled morning, while still fasting, you take one ezetimibe/atorvastatin 10 mg/80 mg tablet. the tablet is swallowed whole with a glass of water.

    The tablet contains two medicines: ezetimibe, which helps reduce the amount of cholesterol absorbed from food, and atorvastatin, which reduces the amount of cholesterol produced by the liver.

    The dose is taken only once during this period.

  3. Step 3

    Blood sample collection after first dose

    After taking the tablet, you remain at the study site for a series of short visits. at each visit a small amount of blood is drawn to measure how the medicines are absorbed and processed in your body.

    Blood samples are collected at several time points over the next 72 hours. you may be asked to stay seated or rest between collections.

  4. Step 4

    Washout period

    After the last blood draw, you return to your normal routine. no study medication is taken during this time.

    A washout period of several days (the exact length is determined by the study protocol) allows the medicines to leave your system before the next dosing period.

  5. Step 5

    Second dosing period

    You return for the second dosing day and again fast for at least 8 hours before the visit.

    You take a single ezetimibe/atorvastatin 10 mg/80 mg tablet of the opposite formulation (the commercial film‑coated tablet if the first dose was the test tablet, or vice‑versa). the tablet is swallowed with water.

  6. Step 6

    Blood sample collection after second dose

    As after the first dose, a series of blood draws is performed over the next 72 hours to compare how the two tablet types are absorbed.

    The same schedule of sample times is used, allowing a direct comparison between the two formulations.

  7. Step 7

    Final visit and study completion

    After the last blood sample, you attend a final visit where the study staff review any remaining questions and confirm that all study procedures are finished.

    You receive information about how the study results will be used, but no further medication is required.

Who can join the trial?

7 criteria

  • You must give written consent after the study team explains the study, possible risks, and your right to stop at any time.
  • You must be between 18 and 55 years old.
  • You must be in good overall health, meaning you do not have any important organic (body organ) problems or psychic (mental) conditions.
  • Your medical records and physical examination must not show any important abnormalities.
  • Your blood tests (haematology – blood cell counts, coagulation – clotting ability, biochemistry – chemicals in blood, and serology – tests for hepatitis B, hepatitis C, and HIV) and urine test (urinalysis) must be normal.
  • Your basic health measurements (vital signs such as blood pressure, pulse, temperature) and heart test called an electrocardiogram (ECG) must be normal.
  • Both men and women are allowed to join the study.

Who cannot join the trial?

14 criteria

  • People who have any serious physical illness or mental health condition, or who have abnormal blood test results showing possible liver or kidney problems (such as high levels of liver enzymes called GOT, GPT, or GGT, or high bilirubin levels) cannot join the study.
  • Anyone who drinks alcohol every day or had an episode of alcohol poisoning in the past week is not allowed to participate.
  • People who gave blood within the last month before the study starts must be excluded.
  • Women who are pregnant, breastfeeding, or could become pregnant without using a reliable birth‑control method are not eligible.
  • Individuals who cannot tolerate lactose (the sugar found in milk) are excluded.
  • People with rare inherited conditions that make it difficult to process galactose (a sugar related to lactose), such as certain forms of lactase deficiency, cannot take part.
  • Anyone who has taken part in another clinical trial with a new drug within the past three months (or one month for a marketed drug) must not join.
  • Participants must be able to follow study instructions and cooperate; those who cannot do so are excluded.
  • People who have a history of trouble swallowing are not eligible.
  • Anyone who has taken prescription medication in the last 15 days, or any medication in the 48 hours before the study drug (except for approved birth‑control pills) cannot participate.
  • Individuals whose body mass index (BMI) is lower than 18.5 or higher than 30.0 are excluded.
  • Those who have ever had an allergic reaction or sensitivity to any medication are not allowed.
  • People who test positive for illegal drugs such as cannabis, opiates, cocaine, or amphetamines are excluded.
  • Current smokers are not eligible to join the study.
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Investigated drugs

  • Ezetimibe/atorvastatin (test tablet)

    is a combined pill that contains two medicines: ezetimibe, which helps lower the amount of cholesterol absorbed from food, and atorvastatin, which reduces the amount of cholesterol made by the liver. In this study the test tablet was given to healthy volunteers to see how much of the medicine reaches the bloodstream and how quickly it works, compared with the reference product.

  • ATOZET (film‑coated tablet)

    is the commercial version of the same combination of ezetimibe and atorvastatin, but it is made as a film‑coated tablet. It was used as the comparator in the trial, meaning the researchers measured its performance under the same conditions to determine whether the test tablet works in the same way and can be considered equivalent.

What is already known about the treatment

Ezetimibe/Atorvastatin Normogen - It is taken by mouth as a tablet that contains 10 mg ezetimibe and 80 mg atorvastatin. Both drugs are approved and well documented in medical literature. The combination is used to lower high cholesterol and help prevent heart disease. Ezetimibe blocks cholesterol absorption from food, and atorvastatin, a statin, lowers cholesterol made by the liver, so together they act as a cholesterol‑lowering medicine. ATOZET - It is taken by mouth as a film‑coated tablet with 10 mg ezetimibe and 80 mg atorvastatin. These ingredients are approved medicines and are extensively described in scientific publications. The product is prescribed to reduce high cholesterol levels and lower the risk of cardiovascular problems. Ezetimibe prevents intestinal cholesterol uptake, while atorvastatin (a statin) reduces liver cholesterol production, providing a combined lipid‑lowering effect.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506559-10-00Protocol codeN-EZEATO-23-280Estimated enrolment36 patientsSponsorLaboratorios Normon S.A.

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