3s Pharmacological Consultation & Res. S.R.L.
Verified
Cumparatura, Romania
Not recruiting
Bioequivalence of a fixed‑dose combination of acetylsalicylic acid, atorvastatin and ramipril versus separate tablets in healthy adult volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study looks at medicines that are commonly used to lower high cholesterol, lower high blood pressure, and reduce the risk of heart disease. The test product is a single capsule that contains three active ingredients: atorvastatin (a cholesterol‑lowering drug), ramipril (a blood‑pressure medication), and acetylsalicylic acid (a low‑dose aspirin that helps prevent blood clots). These same three medicines are also available as separate tablets, which are taken together in current practice.
The purpose of the study is to see whether the single capsule provides the same amount of each medicine in the bloodstream as taking the three separate tablets. Healthy volunteers will receive the combined capsule on one visit and the three individual tablets on another visit, each time after a short fast (no food before taking the medicine). Small blood samples will be taken after each dose to measure how much of each drug appears in the blood, which shows whether the two ways of taking the medicines are equivalent. The study follows a random order of dosing and includes several repeat visits to ensure reliable results.
The research process
The trial runs in 12 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
16 criteria
- Must be a male or female, healthy volunteer who is older than 18 years.
- Must avoid eating or drinking grapefruit, Seville orange, or pomelo (including juices) for 72 hours before and 72 hours after taking the study medication.
- Must be able to understand the study’s purpose, possible risks, and follow all study instructions.
- Must give a written, voluntary consent before any screening procedures.
- For women only: must not be breastfeeding (non‑lactating).
- For women only: must have a negative result on a pregnancy test.
- For women only: must use an effective non‑hormonal method of contraception (condoms, intra‑uterine device, sponge, diaphragm, or a combination) or abstain from sex from screening until the follow‑up visit or three weeks after treatment, whichever is longer.
- Must have a negative COVID‑19 test.
- Must have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m² (a measure of weight relative to height).
- Must have normal blood counts (haematology), blood chemistry (clinical chemistry), and urine tests (urinalysis); small differences that are not clinically important are allowed.
- Must have no kidney problems (renal impairment) and no liver problems (hepatic impairment).
- Must have no heart diseases (cardiovascular) or serious lung diseases (respiratory).
- Must have no current or past infectious disease that is acute (sudden) or chronic (long‑lasting).
- Must be a non‑smoker or have quit smoking for at least two years before the study.
- Must avoid alcohol for 48 hours before and 72 hours after taking the study medication.
- Must avoid foods or drinks containing methylxanthines (such as coffee, tea, cola, energy drinks, chocolate), St John’s Wort, and chewing gum for 48 hours before and 72 hours after taking the study medication.
Who cannot join the trial?
30 criteria
- Allergy to any of the study medicines, medicines that are similar, or any of the inactive ingredients in the pills.
- Haemophilia (a blood‑clotting disorder known as type A, B, or C).
- History of serious stomach bleeding, a hole in the stomach, or having had part or all of the stomach removed.
- History of achlorhydria (no stomach acid) or surgery that bypasses or removes the first part of the small intestine called the duodenum.
- Significant disease of the gallbladder or bile ducts, liver tumors, or any liver function problems.
- Chronic inflammatory bowel disease such as Crohn’s disease or ulcerative colitis.
- Heart rate below 60 or above 100 beats per minute, body temperature below 35.5 °C or above 37.4 °C, breathing rate below 14 or above 20 breaths per minute, or blood pressure lower than 90/50 mmHg or higher than 140/90 mmHg at the screening visit.
- Abnormal heart test results (ECG) that are considered clinically important.
- Creatine phosphokinase (an enzyme that shows muscle damage) more than five times the normal upper limit.
- AST or ALT (liver enzymes) more than three times the normal upper limit.
- Blood potassium level higher than the normal range.
- Rare inherited problems that affect how the body handles sugar, such as lactase deficiency (cannot digest lactose), glucose‑galactose malabsorption, or gluten intolerance (celiac disease).
- Significant narrowing of both kidney arteries or narrowing of the kidney artery when only one kidney is working.
- Active viral infection within the past four weeks.
- Vaccination within the past two weeks.
- Any drug or alcohol abuse, recent psychiatric disorder, or use of medicines that affect the mind within the last two years.
- Any condition that could change how the study medicines are absorbed, moved, broken down, or removed from the body.
- Any current acute (sudden) or chronic (long‑lasting) infection.
- Positive test for HIV, hepatitis B, or hepatitis C.
- Being vegetarian or following a special diet that requires long periods without eating.
- History of difficulty donating blood.
- Difficulty swallowing solid tablets or capsules.
- Participation in another clinical study with a new investigational drug in the past three months or with a generic drug in the past two months.
- Known or suspected inability to follow study rules, unreliability, inability to understand study information, or financial circumstances that could affect the decision to join.
- Hospital stay for any reason within eight weeks before the study starts.
- Planned hospitalization within three months after the last dose of the study drug.
- Donation of 450 ml or more of blood within eight weeks before the study, or donation of plasma within 14 days before the study.
- Taking any prescription or over‑the‑counter medication during the two weeks before the study or while in the study.
- History or presence of any serious medical condition such as cancer, major kidney, liver, stomach, lung, heart, hormone, bone, blood, or nerve disorders, or any metabolic or blood disorder.
- History or current presence of clotting problems, such as blood clots in arteries or veins, pulmonary embolism (clot in the lungs), deficiency of clotting factors, stroke, chest pain (angina), heart attack, coronary artery disease, or porphyria (a rare blood disorder).
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Investigated drugs
Cardyl
is a film‑coated tablet that contains atorvastatin. Atorvastatin belongs to a group of medicines called statins, which are used to lower cholesterol and reduce the risk of heart disease. In this study, Cardyl was given as one of the separate reference medicines to compare with the combined pill.
Aspirin N
is a tablet that contains acetylsalicylic acid, commonly known as aspirin. Aspirin helps prevent blood clots by making the blood less likely to clot, which can lower the chance of heart attacks and strokes. In the trial, Aspirin N was taken together with the other reference tablets to represent the standard treatment.
Acovil
is a tablet that contains ramipril. Ramipril is an ACE‑inhibitor that relaxes blood vessels, helping to lower blood pressure and protect the heart. In this study, Acovil was used as the individual reference medicine for the blood‑pressure component.
Cardiovascular Pill AAR
is a hard‑capsule polypill that combines three medicines—atorvastatin, ramipril, and acetylsalicylic acid—into one single dose. This combined pill is intended to lower cholesterol, reduce blood pressure, and prevent blood clots all at once. In the trial, the polypill was the test product whose overall effect and absorption were compared to taking the three separate reference tablets together.
What is already known about the treatment
Atorvastatin (Cardyl 80 mg film‑coated tablet)
This medication is taken by mouth as a film‑coated tablet, usually once daily. It is a well‑established cholesterol‑lowering drug that has been used for many years in clinical practice. It is mainly prescribed to reduce high LDL cholesterol and lower the risk of heart disease. Atorvastatin works by blocking the liver enzyme HMG‑CoA reductase, which is needed to make cholesterol, and it belongs to the class of statins.
Acetylsalicylic acid (Aspirin® N 100 mg tablet)
The drug is taken orally as a tablet, typically once a day. It is a long‑standing pain reliever and blood‑thinner that is available over the counter. Its main uses are to relieve mild pain or fever and to prevent blood clots that can cause heart attacks or strokes. It blocks the enzyme COX, reducing the production of prostaglandins that help platelets stick together, and it is classified as an NSAID and antiplatelet agent.
Ramipril (Acovil 10 mg tablet)
This medication is taken by mouth as a tablet, usually once daily. It is a widely used treatment for high blood pressure and for protecting the heart after a heart attack. The primary goal is to lower elevated blood pressure and reduce strain on the heart. Ramipril blocks the angiotensin‑converting enzyme (ACE), which relaxes blood vessels, and it belongs to the ACE‑inhibitor class of drugs.
Polypill AAR (fixed‑dose combination capsule 100/80/10 mg)
The test product is an oral hard capsule taken once daily that contains atorvastatin, ramipril, and acetylsalicylic acid together in a single pill. It is a newer fixed‑dose combination designed to simplify cardiovascular risk management by providing cholesterol‑lowering, blood‑pressure‑lowering, and antiplatelet effects in one tablet. The capsule aims to lower LDL cholesterol, control blood pressure, and prevent clot formation, using the same mechanisms as the individual components. It is classified as a cardiovascular polypill (fixed‑dose combination).
Investigated diseases
Hypercholesterolemia
A condition where the blood contains high levels of cholesterol, especially low‑density lipoprotein (LDL). Over time, excess cholesterol can deposit in the walls of arteries, forming fatty streaks. These streaks gradually enlarge into plaques that narrow the vessel lumen. As plaques grow, blood flow to organs can become restricted. The disease often develops silently and may only be detected through blood tests.
Hypertension
Persistent elevation of the pressure within the arterial blood vessels. The increased pressure forces the heart to work harder, which can cause the heart muscle to thicken. The arterial walls may become stiffer, further raising blood pressure. Over many years, the strain can affect the kidneys, eyes, and brain. The condition usually progresses without obvious symptoms until complications arise.
Atherosclerotic cardiovascular disease
A disorder in which plaques made of fat, cholesterol, and cellular debris build up inside the arteries. The plaques can slowly narrow the vessels, limiting blood flow to the heart, brain, or limbs. Occasionally, a plaque may rupture, leading to a clot that blocks the artery completely. This blockage can cause a heart attack, stroke, or limb ischemia. The disease advances over many years and is often silent until an acute event occurs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505572-30-00Protocol codeARA-BESD-14-FRI/23Estimated enrolment56 patientsSponsorFerrer Internacional S.A.
sourced from the EU Clinical Trials Register and site verification
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