Bioavailability Study of Rosuvastatin and Ezetimibe with Bempedoic Acid in Healthy Male and Female Volunteers

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What is this study about?

This study involves healthy adult volunteers and examines how the body absorbs several cholesterol‑lowering medicines. The test medicines are Rosuvastatin/Ezetimibe and Ezehron Duo, each taken together with Nilemdo. The reference combination uses Nustendi together with Crestor. All tablets are taken by mouth.

The purpose of the study is to compare the bioavailability—that is, how much of each drug reaches the bloodstream—of rosuvastatin and ezetimibe when given in the test combinations versus the reference combination.

Each participant will receive a single dose of one of the three combinations while fasting, then after a suitable break will receive the next combination, and so on, so that every volunteer tries each treatment. Blood samples will be drawn after each dose to measure the amount of medication in the blood, allowing researchers to see how quickly and how fully the drugs are absorbed.

1 enrollment and baseline assessments

after joining the study, a brief medical history and physical examination are performed to confirm eligibility.

baseline laboratory tests are taken, and instructions are given to remain fasting (no food or drink except water) for at least ten hours before each dose.

2 first treatment period (treatment a)

under fasting conditions, a single oral dose of the test tablet containing rosuvastatin 20 mg and ezetimibe 10 mg (total 30 mg) is taken together with one Nilemdo 180 mg tablet.

after the dose, small amounts of blood are drawn at several time points up to seventy‑two hours to measure how much drug is in the bloodstream.

the collected data are used to calculate measures such as AUC (total exposure) and Cmax (maximum concentration).

3 washout period after first treatment

a washout period is observed to allow the previous medication to leave the body before the next dose is given. during this time no study medication is taken.

4 second treatment period (treatment b)

while still fasting, a single oral dose of the reference tablet containing ezetimibe 10 mg and bempedoic acid 180 mg (named Nustendi) is taken together with one Crestor 20 mg tablet (rosuvastatin).

blood samples are collected at the same schedule as in the first period, up to seventy‑two hours after the dose, to assess drug levels.

5 washout period after second treatment

another washout period is observed to clear the reference medication before the final treatment.

6 third treatment period (treatment c)

under fasting conditions, a single oral dose of the second test tablet named Ezehron Duo, containing ezetimibe 10 mg and rosuvastatin 20 mg (total 30 mg), is taken together with one Nilemdo 180 mg tablet.

blood sampling is performed again up to seventy‑two hours after the dose to gather comparable data.

7 final follow‑up and study completion

after the last blood collection, a final safety check is performed and any remaining study procedures are completed.

the participant is then discharged from the study without further obligations.

Who Can Join the Study?

Be a healthy man or a woman who is not pregnant and not breastfeeding, aged between 18 and 60 years, and of Caucasian race.
Be a non‑smoker or a former smoker who stopped smoking at least 6 months before the first dose.
Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m² (a measurement that compares weight to height).
Be able to stay in the study for its entire duration and sign a written informed consent (an agreement that you understand the study and agree to take part).
Be in good health as shown by medical history, a physical exam, normal vital signs (heart rate, blood pressure, and body temperature), and a 12‑lead ECG (a test that records the heart’s electrical activity). Small differences that are not important to health are allowed.
Have all laboratory test results within the normal range or considered not important for health by the doctor.
Agree to use contraceptive measures (methods to prevent pregnancy) for the entire study, whether you are male or female.
Be able to speak and understand Czech fluently.

Who Cannot Join the Study?

Having any serious ongoing illness that could affect the study results or make the drug unsafe.
Body temperature not between 35.7°C and 36.9°C when screened or checked in.
Sitting blood pressure after at least five minutes of rest outside the range of 90‑140 mmHg (systolic) or 60‑90 mmHg (diastolic), or a heart rate outside 50‑100 beats per minute during screening.
Existing stomach or intestinal problems, kidney disease, liver disease, or other abnormal findings that could change how the drug works or is absorbed.
Any major abnormal test result, including a positive test for hepatitis B, hepatitis C, or HIV.
Having anemia (low red blood cell count) – hemoglobin below 120 g/L for women or below 130 g/L for men.
Positive pregnancy test, being breast‑feeding, or not having a pregnancy test result.
Less than 45 days since finishing another clinical study.
History or presence of a serious illness that could affect how the drug is absorbed, spread, broken down, or removed by the body.
Severe allergy or allergic reaction to the study drug, related medicines (such as ACE inhibitors or certain blood‑pressure drugs), or any of the inactive ingredients.
Significant illness within 28 days before the first dose, including major surgery.
Use of medicines that change liver metabolism within 90 days before the first dose.
Serious mental illness or inability to cooperate with study staff.
History of orthostatic hypotension (a drop in blood pressure when standing up) or showing it during screening.
Abuse of drugs, alcohol (40 g of pure alcohol per day for men or 20 g for women), solvents, or excessive caffeine.
Use of drugs that can damage major organs within 90 days before the first dose (for example, chloramphenicol, which can suppress bone‑marrow function).
Active liver disease or liver enzyme levels (ALT, AST, GGT) that are three times higher than the normal upper limit.
Abnormal creatine kinase (CK) levels unless the investigator decides it is not important.
Poor kidney function with a creatinine clearance (MDRD) less than 1 mL/s.
Current or past muscle problems such as muscle toxicity, myopathy, rhabdomyolysis, muscle injuries, or a family history of inherited muscle disorders.
History of lactose intolerance, galactose intolerance, or glucose‑galactose malabsorption syndrome.
Current or past underactive thyroid (hypothyroidism).
Any prescription medication taken within 28 days before the first dose, except stable hormonal contraceptives or hormone replacement taken without dose changes for 90 days.
Current or past high uric acid levels (hyperuricemia) or gout.
Inability to swallow a large tablet.
Use of any over‑the‑counter medicines, vitamins, herbal products (such as St. John’s Wort), or food supplements within 14 days before the first dose.
Donation or loss of at least 500 mL of blood within 90 days, or donation of plasma or platelets within 14 days before the first dose.
Getting a tattoo, body piercing, or any cosmetic skin procedure that penetrates the skin within 90 days before screening, unless the investigator decides it is not significant.
Positive test for illegal drugs in urine at screening or check‑in.
Positive breath test for alcohol at screening or check‑in.
Positive urine test for cotinine (a marker of nicotine use) at screening.

Where you can join this trial?

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Site Name	City	Country	Status
Qhcajqcquafnkfgv scbkrx	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	11.10.2023

Trial locations

Investigated Drugs:

Rosuvastatin/Ezetimibe is a single tablet that contains two medicines: rosuvastatin, which helps lower “bad” cholesterol (LDL), and ezetimibe, which reduces the amount of cholesterol your body absorbs from food. In this study it is given as the test medication to see how well it is absorbed when taken with another drug.

Nilemdo is a tablet that contains bempedoic acid, a medicine that also lowers cholesterol by working on the liver. In the trial it is taken together with the test tablet (Rosuvastatin/Ezetimibe) to see how the two drugs affect each other’s absorption.

Nustendi is a combination tablet that includes ezetimibe and bempedoic acid. It is used as a comparator (reference) drug in the study, and it is taken together with Crestor to compare its performance with the test combination.

Crestor is a tablet that contains rosuvastatin alone. It is the reference cholesterol‑lowering medicine that is given with Nustendi to provide a standard against which the test combination is measured.

Heparin is an injectable medication that prevents blood clots. In this study it is given to all participants as a background therapy to keep blood clotting under control while the other drugs are being tested.

Healthy volunteers – These are individuals without diagnosed cardiovascular disease, used to assess how the body processes the medication.

Trial ID:

2023-507048-35-00

Protocol code:

950/23

Trial Phase:

Human Pharmacology (Phase I) – Other

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Bioavailability Study of Rosuvastatin and Ezetimibe with Bempedoic Acid in Healthy Male and Female Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?