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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

A study is being done with people who are healthy and do not have any illness. The participants will take a single dose of a combined medication that contains ezetimibe and atorvastatin, which are medicines used to lower cholesterol levels in the blood. Two different tablet forms of this combination are being compared: one is a regular tablet and the other is a film‑coated tablet.

The main goal of the study is to see if the two tablet forms deliver the medicines to the body in the same amount and at the same speed, a concept known as bioequivalence. This helps determine whether the new tablet works just as well as the already available version.

Volunteers will come to the study site, fast for a short period, take one of the tablets, and then have a few short check‑ins where a small blood sample may be taken to measure how much of the medicines entered the bloodstream. After a wash‑out period, the participants will return to receive the other tablet and repeat the same short monitoring. The whole process involves only a single dose of each tablet and a brief follow‑up, without any long‑term treatment.

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

    Fasting before first dose

    You will be asked to refrain from eating or drinking anything except water for at least 10 hours before the first tablet is taken. this ensures the medication is absorbed under fasting conditions.

  2. Step 2

    First dose administration

    You will receive one tablet that contains 10 mg ezetimibe and 40 mg atorvastatin. the tablet may be the test formulation (ezetimibe/atorvastatin normogen 10 mg/40 mg) or the reference formulation (atozet 10 mg/40 mg film‑coated tablet), depending on the random assignment. the tablet is taken by mouth with a small amount of water.

    The dose is a single administration; no additional tablets are taken during this period.

  3. Step 3

    Blood sampling after first dose

    After the tablet is swallowed, a series of blood samples will be collected at several time points to measure the levels of atorvastatin and ezetimibe in your blood. these samples help determine how much of the drug is absorbed and how quickly it appears in the bloodstream.

  4. Step 4

    Washout period

    Following the first sampling phase, you will have a washout period during which no study medication is taken. this interval allows the drug to be cleared from your body before the next tablet is given. the exact length of the washout period is determined by the study protocol.

  5. Step 5

    Second dose administration

    After the washout period and another fasting period of at least 10 hours, you will take a second tablet. this tablet contains the same amounts of ezetimibe (10 mg) and atorvastatin (40 mg) but is the opposite formulation from the first dose (if the first was the test, the second will be the reference, and vice versa).

    Again, this is a single oral dose taken with a small amount of water.

  6. Step 6

    Blood sampling after second dose

    A second series of blood samples will be collected at the same time points as after the first dose. these measurements allow comparison of the two formulations.

  7. Step 7

    Study completion

    Once the second sampling phase is finished, the study procedures are complete. no further medication is required.

Who can join the trial?

6 criteria

  • Written consent: after learning about the study’s purpose, possible risks, and the right to stop at any time, the person must sign a document agreeing to take part.
  • Age must be between 18 and 55 years.
  • No significant organic (body) or psychic (mental) health problems.
  • Medical records and physical exam must show no important abnormalities.
  • Blood tests (haematology, coagulation, biochemistry, serology) and urine tests must be normal; this includes checks for hepatitis B, hepatitis C, and HIV infections.
  • Vital signs (such as blood pressure and heart rate) and an electrocardiogram (ECG) must be within normal limits.

Who cannot join the trial?

14 criteria

  • Having any serious physical or mental illness, or lab test results that show abnormal kidney or liver function (for example, liver enzymes called GOT, GPT, or GGT that are more than 2.5 times the normal limit, or a blood substance called total bilirubin that is more than 1.5 times normal unless the direct form is less than 35%).
  • Drinking alcohol every day or having an episode of alcohol poisoning within the past week.
  • Donating blood within the last month before the study starts.
  • Being pregnant or breastfeeding. Women who could become pregnant must use a reliable birth‑control method or avoid sexual activity during the study.
  • Being unable to tolerate lactose (the sugar found in milk).
  • Having rare inherited problems that prevent the body from processing galactose (a sugar in milk) or from breaking down lactose, such as galactose intolerance or Lapp lactase deficiency.
  • Having taken part in another clinical trial with experimental drugs in the past three months (or at least one month if the other trial used a drug already on the market).
  • Being unable to follow the study instructions or cooperate with the research staff.
  • Having difficulty swallowing pills.
  • Taking any prescription medication in the last 15 days, or any medication in the 48 hours before receiving the study drug (except allowed contraceptives, which must have been used for at least four weeks and not changed).
  • Having a body mass index (BMI) outside the range of 18.5 to 30.0 (BMI is weight in kilograms divided by height in meters squared).
  • Having a known allergy or sensitivity to any medication.
  • Testing positive for illegal drugs such as cannabis, opiates, cocaine, or amphetamines (positive drug screening).
  • Being a smoker.
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Investigated drugs

  • Ezetimiba/Atorvastatina Normogen tablets

    are a combined oral tablet that contains two medicines: ezetimibe, which reduces the amount of cholesterol absorbed from food, and atorvastatin, which lowers the amount of cholesterol made by the liver. In this study the tablet is the “test” product, meaning it is a new formulation that researchers want to see if it works the same way as an already‑approved version. Healthy volunteers take a single dose of this tablet while fasting, and blood samples are collected to measure how much of each medicine becomes available in the body.

  • ATOZET tablets

    are a commercially available, film‑coated oral tablet that also contains ezetimibe and atorvastatin in the same combination. This product serves as the “comparator” or reference in the trial. By giving volunteers the same single dose of this tablet under the same conditions, researchers can compare how the test tablet is absorbed and processed, checking whether the new formulation is bioequivalent to the established one.

What is already known about the treatment

  • Ezetimiba/Atorvastatina Normogen 10 mg/40 mg comprimidos

    This product is a tablet taken by mouth, usually once after a fast. It contains ezetimibe and atorvastatin, both of which are approved and widely used to lower cholesterol levels. Ezetimibe works by stopping the gut from absorbing cholesterol, while atorvastatin reduces the amount the liver makes, together helping to keep blood cholesterol in a healthy range. The medication belongs to the lipid‑lowering class, combining a cholesterol‑absorption inhibitor with a statin.

  • ATOZET 10 mg/40 mg comprimidos recubiertos con película

    This is a film‑coated tablet that is swallowed orally, also given as a single dose on an empty stomach. It contains the same two ingredients, ezetimibe and atorvastatin calcium, which are both approved and commonly prescribed for high cholesterol. The drug works by the same dual action: blocking dietary cholesterol absorption and lowering the liver’s cholesterol production, helping to reduce overall blood cholesterol. It is classified as a combination lipid‑lowering therapy, joining a statin with a cholesterol‑absorption inhibitor.

Investigated diseases

Healthy volunteers - Individuals without known medical conditions who maintain normal physiological function. They typically have stable blood lipid levels and no symptoms of disease. Their bodies process medicines in a standard manner without disease-related alterations. Over time, they remain free of illness unless exposed to external factors. Their health status allows clear assessment of how a drug behaves in a normal system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507226-16-00Protocol codeN-EZEATO-23-283Estimated enrolment36 patientsSponsorLaboratorios Normon S.A.

sourced from the EU Clinical Trials Register and site verification

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