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Comparison of rosuvastatin/ezetimibe tablets versus capsules in healthy volunteers: A single-dose bioequivalence study of 20 mg/10 mg formulations

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

This study examines two different forms of a combination medication containing rosuvastatin and ezetimibe, which are drugs used to lower cholesterol levels in the blood. The study compares a film-coated tablet version to a hard capsule version of the same medication. Both forms contain the same amount of active ingredients - 20 mg of rosuvastatin and 10 mg of ezetimibe.

The purpose of the study is to determine if both forms of the medication work similarly in the body. The study involves healthy volunteers who will take a single dose of each form of the medication at different times. The medication will be given by oral administration (taken by mouth) when participants have not eaten (fasting conditions).

During the study, researchers will measure how much of each active ingredient enters the bloodstream and how quickly this happens. This type of study, known as a bioequivalence trial, helps determine if the two different forms of the medication have the same effect in the body. The study uses a crossover design, which means each participant will receive both forms of the medication at different times during the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive a single oral dose of either rosuvastatin/ezetimibe 20 mg/10 mg film-coated tablets or rosuvastatin/ezetimibe 20 mg/10 mg hard capsules

    The medication must be taken under fasting conditions

  2. Step 2

    Monitoring period

    Your blood samples will be collected to measure drug levels over a period of 72 hours

    Medical staff will monitor two main aspects of the medication in your blood:

    - The maximum concentration of the drugs (Cmax)

    - The total exposure to the drugs over time (AUC)

  3. Step 3

    Washout period

    A break period will follow to ensure the first medication is completely eliminated from your body

  4. Step 4

    Second medication administration

    You will receive a single dose of the other medication form (either the tablet or capsule, whichever you did not receive in step 1)

    The same monitoring process from step 2 will be repeated

  5. Step 5

    Study completion

    The study will conclude after the final blood sample collection

    Your participation will help determine if both medication forms work similarly in the body

Who can join the trial?

10 criteria

  • Must be willing to give written consent after being informed about the study details, risks, and right to withdraw at any time
  • Must be between 18 and 55 years old
  • Must not have any significant physical or mental health conditions
  • Must have normal results from physical examination and medical history review
  • Must have normal results in:
    • Blood tests (including blood cell counts and clotting)
    • Biochemistry tests (measuring various substances in blood)
    • Serology tests (checking for hepatitis B, hepatitis C, and HIV)
    • Urinalysis (urine tests)
    • Must have normal:
      • Vital signs (blood pressure, heart rate, temperature, breathing rate)
      • Electrocardiogram (heart rhythm test)

Who cannot join the trial?

15 criteria

  • History of allergic reactions or hypersensitivity to rosuvastatin, ezetimibe, or similar medications
  • Participation in another clinical trial within the past 3 months
  • Current pregnancy or breastfeeding
  • Significant medical conditions affecting liver function (liver is where these medications are processed)
  • Kidney problems or abnormal kidney function tests
  • Use of medications that could interact with the study drugs
  • History of drug or alcohol abuse within the past year
  • Smoking more than 10 cigarettes per day
  • Abnormal blood pressure readings (too high or too low)
  • Significant heart problems or abnormal heart rhythm
  • Blood disorders or abnormal blood test results
  • Major surgery within the past 3 months
  • Body Mass Index (BMI) outside the range of 18.5-30 kg/m² (measurement of body fat based on height and weight)
  • Unable to provide informed consent
  • History of muscle problems or elevated muscle enzymes
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Investigated drugs

Rosuvastatin/Ezetimibe is a combination medication used to lower cholesterol levels in the blood. Rosuvastatin belongs to a group of drugs called statins that reduce the amount of cholesterol made by the liver, while ezetimibe works by reducing the amount of cholesterol absorbed from food in the digestive tract. Together, these medications help manage high cholesterol levels more effectively than either medication alone. The trial compares two different forms of the same medication: a film-coated tablet version and a hard capsule version. Both forms contain the same active ingredients but are manufactured differently to determine if they work equally well in the body.

What is already known about the treatment

  • Rosuvastatin

    A prescription medication that belongs to the statin class of drugs, administered orally in the form of film-coated tablets or hard capsules. It works by blocking an enzyme in the liver that produces cholesterol, effectively lowering LDL (bad) cholesterol and triglycerides while raising HDL (good) cholesterol levels in the blood. This medication is primarily used to treat high cholesterol and to reduce the risk of heart disease, with clinical studies showing significant effectiveness in preventing cardiovascular events.

  • Ezetimibe

    An oral medication that reduces cholesterol absorption in the small intestine, available in combination with rosuvastatin as film-coated tablets or hard capsules. It works by preventing the absorption of cholesterol from food and bile acids in the intestines, complementing the cholesterol-lowering effects of statins. This medication is commonly prescribed alongside statins for patients who need additional help in managing their cholesterol levels when statins alone are not sufficient to reach target cholesterol levels.

Investigated diseases

Hypercholesterolemia - A condition characterized by elevated levels of cholesterol in the blood, particularly LDL (low-density lipoprotein) cholesterol. It develops when the body creates too much cholesterol or fails to remove it efficiently. The condition can be inherited from parents (familial hypercholesterolemia) or develop due to lifestyle factors. Over time, excess cholesterol can accumulate in blood vessel walls, forming deposits called plaques. This condition often progresses without noticeable symptoms in its early stages.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501862-24-00Protocol codeN-ROSEZE-22-274Estimated enrolment54 patientsSponsorLaboratorios Normon S.A.

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