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

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What is this study about?

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.

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 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 Washout period

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

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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hxvlfixk Ukpuiddfhggum Dm Ln Pxeuydzq Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
14.11.2022

Trial locations

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.

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 ID:
2022-501862-24-00
Protocol code:
N-ROSEZE-22-274
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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