Not recruiting

A study comparing the absorption of rosuvastatin, amlodipine, and ramipril in healthy men and women.

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What is this trial about?

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

This study aims to evaluate the bioequivalence, which is a way to determine if a new version of a medicine works in the same way as the existing version, of a combination medication containing rosuvastatin, amlodipine, and ramipril. These substances are typically used to treat conditions such as high blood pressure and high cholesterol. The test medication is provided in a single hard capsule containing all three active ingredients.

The investigation compares this single capsule to three separate medications taken at the same time: Crestor, Norvasc, and Tritace. Participants in the study will undergo a process where they receive different treatments during two different periods. This cross-over approach means that each person will receive both the combination capsule and the individual tablets at different times to allow for a direct comparison of how the body processes the medicine.

During the study, the way the body absorbs and uses the substances will be monitored while participants are in a fasting state, meaning they will not eat before taking the medication. The focus is on how the medication moves through the body after it is swallowed.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
First period
The first period begins with the administration of a single dose of medication under fasting conditions, which means no food is consumed for a specific period before and after taking the dose.
During this period, one of two options is provided: either a single capsule containing rosuvastatin (10 mg), amlodipine (5 mg), and ramipril (5 mg) is taken, or three separate tablets are taken: crestor (10 mg), norvasc (5 mg), and tritace (5 mg).
Step 2
Washout period
A washout period follows the first period. this is a scheduled interval of time intended to ensure that the medication from the first period is completely cleared from the body before the next stage begins.
Step 3
Second period
The second period involves the administration of the alternative medication option under the same fasting conditions used in the first period.
If the single capsule containing rosuvastatin (10 mg), amlodipine (5 mg), and ramipril (5 mg) was taken in the first period, the three separate tablets—crestor (10 mg), norvasc (5 mg), and tritace (5 mg)—are taken in this period. if the three separate tablets were taken during the first period, the single capsule is taken during this period.

Who can join the trial?

11 criteria

Participants must be males or females who are not pregnant and not breastfeeding.
Participants must be between 18 and 60 years old on the day they sign the agreement to join the study.
The study is looking for people of Caucasian race.
You must be a non-smoker or a former smoker who has not smoked for at least 3 months before taking the first dose.
Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be between 18.5 and 30.0 kg/m2.
You must be able to participate for the entire duration of the study and provide written permission to join.
You must be in good health, which will be checked through your medical history, a physical exam, and vital signs, which include your heart rate, blood pressure (the force of blood against your artery walls), and body temperature.
A 12-lead ECG, which is a test that records the electrical activity of your heart, must show normal results.
All laboratory tests, such as blood or urine tests, must show results within the normal range.
Both men and women must agree to use contraception, which are methods used to prevent pregnancy, throughout the study and for a period after it ends.
You must be able to speak and understand Czech fluently.

Who cannot join the trial?

35 criteria

Having any acute or chronic diseases (short-term or long-term illnesses) or medical findings that could interfere with how the study drug works or affects your safety.
Using systemic drugs (medicines that travel through the whole body) that are known to change how the liver metabolizes (breaks down) medicine within 90 days before the first dose.
Taking any prescription treatment within 28 days before the first dose, except for hormonal contraceptives (birth control) or hormone replacement therapy that has not changed in dose for 90 days.
Taking any over-the-counter (medicines bought without a prescription), vitamins, herbal treatments (such as Saint John's Wort), or food supplements within 14 days before the first dose.
Donating or losing at least 500 mL of blood within 90 days, or donating plasma (the liquid part of blood) or platelets (cells that help blood clot) within 14 days before the first dose.
Getting a tattoo, body piercing, or any cosmetic procedure that pierces the skin within 90 days of the screening, unless a doctor decides it is not important for the study.
Testing positive for drugs of abuse in a urine test during screening or when checking in.
Testing positive for alcohol via a breath test during screening or when checking in.
Testing positive for cotinine (a substance found in the body after using tobacco or nicotine) in a urine test during screening.
Having a body temperature outside the range of 35.7-36.9 °C during screening or check-in.
Having sitting blood pressure outside the range of 105-140 mmHg for systolic (the top number, pressure when the heart beats) or 70-90 mmHg for diastolic (the bottom number, pressure when the heart rests), or a heart rate outside 50-100 beats per minute.
Having existing gastrointestinal (stomach or bowel), renal (kidney), or hepatic (liver) diseases or conditions that could affect how the drug is absorbed or handled by the body.
Any significant medical abnormality, such as testing positive for HBsAg (Hepatitis B), HCV (Hepatitis C), or HIV (a virus that affects the immune system).
Having anaemia (low red blood cell count), specifically haemoglobin levels below 120 g/L for women or 130 g/L for men.
Testing positive for pregnancy via blood or urine tests, being breastfeeding, or being unable to provide pregnancy test results.
Having less than 45 days between finishing a previous study and starting this one.
Having liver disease with high levels of serum transaminases (enzymes in the blood that indicate liver health), specifically ALT, AST, or GGT levels at or above 3 times the upper limit of normal.
Having serum sodium or potassium levels outside the normal range, unless a doctor decides it is not significant.
Having creatine kinase (CK) levels (an enzyme related to muscles) outside the normal range, unless a doctor decides it is not significant.
Having impaired kidney function, measured by a creatinine clearance (MDRD) of less than 1 mL/s.
Having current or past skeletal muscle disorders (such as myopathy or rhabdomyolysis, which is muscle breakdown) or muscle injuries, or a family history of hereditary muscle problems.
A history of angioedema (severe swelling under the skin).
A history of serious illness that could change how drugs are absorbed (taken in), distributed (moved around), metabolized (broken down), or eliminated (removed) from the body.
A current or past history of heart failure, hypertension (high blood pressure), aortal or mitral valve stenosis (narrowing of the heart valves), or hypertrophic cardiomyopathy (thickening of the heart muscle).
A history or presence of lactose intolerance, galactose intolerance, or glucose-galactose malabsorption syndrome (problems digesting certain sugars).
Current or past hypothyroidism (an underactive thyroid).
Having received a COVID-19 vaccine less than 14 days before screening or planning to be vaccinated during the study.
Being hospitalized because of COVID-19.
Testing positive for SARS-CoV-2 (the virus that causes COVID-19) via a PCR or antigen test if required for safety.
A history of, or severe allergy to, the study drugs, related medicines (like ACE inhibitors or dihydropyridine derivatives), or any excipients (inactive ingredients in a medicine).
Any significant illness or major surgery within 28 days before the first dose.
Having a serious mental disease or being unable to cooperate with the medical team.
A history of or experiencing orthostatic hypotension (a sudden drop in blood pressure when standing up).
Abuse of drugs, alcohol (more than 40g of pure ethanol per day for men or 20g for women), solvents (chemical liquids), or caffeine.
Using organ-toxic drugs (medicines that can damage organs) within 90 days before the first dose, such as those that cause bone marrow suppression (reduced ability of the body to produce blood cells).

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Verified
Quinta-Analytica s.r.o.
Prague, Czechia

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Investigated drugs

Rosuvastatin/Amlodipine/Ramipril
is a combination medication that includes three different medicines in one capsule to treat conditions related to heart health and cholesterol. It contains rosuvastatin to help lower cholesterol, amlodipine to help relax blood vessels and lower blood pressure, and ramipril to also help lower blood pressure.
Ramipril
is a medication used to treat high blood pressure and to protect the heart.
Amlodipine
is a medication used to treat high blood pressure by relaxing the muscles of your heart and blood vessels.
Rosuvastatin
is a medication used to lower high cholesterol levels in the blood.

What is already known about the treatment

Ramipril
This medication is taken orally in the form of a tablet and is widely used to treat high blood pressure and protect the heart. It belongs to a class of drugs called ACE inhibitors, which work by blocking a specific enzyme in the body that causes blood vessels to tighten. By preventing this process, the medicine helps the blood vessels relax and widen, making it easier for blood to flow.
Amlodipine
Administered orally as a tablet, this well-established medication is commonly used to manage high blood pressure and chest pain. It is classified as a calcium channel blocker, which functions by preventing calcium from entering the muscle cells of the heart and blood vessels. This action allows the blood vessels to relax, which lowers blood pressure and improves blood circulation.
Rosuvastatin
This medicine is swallowed as a tablet and is a standard treatment used to lower high cholesterol levels and prevent heart disease. It belongs to a group of drugs known as statins, which work by inhibiting a specific enzyme in the liver that is responsible for producing cholesterol. By slowing down this production, the medication helps reduce the amount of bad cholesterol circulating in the bloodstream.

Investigated diseases

Cardiovascular diseases - These are a group of disorders that affect the heart and the blood vessels. They can involve problems with the heart muscle, the electrical system that controls the heartbeat, or the structure of the heart itself. Additionally, these conditions can affect how blood flows through the arteries and veins. Over time, issues such as the buildup of fatty substances in the arteries may restrict blood flow. This process can gradually lead to changes in how the circulatory system functions.