Not recruiting

Interaction study of rosuvastatin with amlodipine, ramipril and heparin sodium in healthy adults

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

The trial involves healthy adult volunteers and examines how three commonly used heart medicines—ramipril, rosuvastatin and amlodipine—behave when taken together compared with taking each one alone. An injectable blood‑thinner called heparin sodium is also given as background treatment during the study.

The purpose of the study is to assess whether a pharmacokinetic interaction occurs when the three tablets are used at the same time. Participants receive a single dose of each medication in separate periods, and in one period they receive all three tablets together, while remaining fasted (no food) before each dose.

A “cross‑over” design means that each participant experiences every treatment sequence, allowing direct comparison within the same person. The study includes four short study periods, each separated by a wash‑out time, and the whole process takes place over a few weeks.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
You receive information about the study and sign a consent form indicating that you agree to take part.
Baseline measurements such as weight, blood pressure, and basic blood tests are recorded before any medication is taken.
Step 2
Fasting before first dosing
You do not eat or drink anything except water for at least eight hours before the scheduled dosing time.
This ensures that food does not affect how the medicines are absorbed.
Step 3
First period dosing (single drug)
According to the random order, you take one of the study tablets by mouth:
tritace 10 mg tablet (contains ramipril) – one tablet, oral, single dose,
crestor 20 mg tablet (contains rosuvastatin) – one tablet, oral, single dose,
Or norvasc 10 mg tablet (contains amlodipine) – one tablet, oral, single dose.
The tablet is swallowed with a small amount of water.
Step 4
Post‑dose observation and blood sampling
After taking the tablet you remain in the clinic for several hours.
Blood samples are drawn at predefined times (for example, a few minutes after dosing and then at several later points up to 72 hours) to measure how the medicine is processed in your body.
An heparin sodium injection (2.4 iu/ml, given intravenously) may be used during blood draws to keep the blood from clotting.
You may be asked to stay overnight if the sampling schedule extends beyond the usual clinic hours.
Step 5
Washout period
After the last blood sample of the first period you return home.
A washout interval (a period with no study medication) is observed to allow the drug to leave your system before the next period begins. the exact length is determined by the study protocol.
Step 6
Second period dosing (single drug)
You repeat the fasting procedure described in step 2.
You take the next study tablet that was not used in the first period, following the same instructions for swallowing with water.
The same post‑dose observation and blood sampling procedures described in step 4 are performed.
Step 7
Third period dosing (single drug)
After another washout interval, you fast again for at least eight hours.
You take the remaining study tablet that has not yet been taken, using the same method as before.
Post‑dose observation and blood sampling are conducted in the same way as in previous periods.
Step 8
Fourth period dosing (combined drugs)
Following the final washout, you fast for at least eight hours.
You take all three study tablets together: tritace 10 mg tablet, crestor 20 mg tablet, and norvasc 10 mg tablet, each swallowed with water.
The same observation period and blood sampling schedule are followed to assess how the medicines interact when taken together.
Step 9
Final assessments and study completion
After the last blood sample of the combined‑drug period, a final set of basic health measurements is taken.
You are thanked for your participation and any study‑related materials are returned.
The study ends for you once all data have been collected.

Who can join the trial?

8 criteria

Be a healthy adult male or a female who is not pregnant and not breastfeeding, aged between 18 and 60 years, and of Caucasian race; pregnancy will be tested during screening.
Do not currently smoke, and if you have smoked before, you must have stopped at least 3 months before the first dose.
Have a Body Mass Index (BMI) between 18.5 and 30.0 (BMI is a simple calculation that compares your weight to your height).
Be able to stay in the study for its entire duration and sign a written informed consent form, which means you agree to take part after understanding what will happen.
Be in good overall health, as shown by a medical history check, physical exam, and normal vital signs (including heart rate, systolic and diastolic 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 are allowed.
All laboratory test results must be within normal limits or considered not important by the doctor.
Agree to use highly effective birth control methods for the whole study and at least 30 days after the last dose. This includes hormonal pills, patches, implants, intrauterine devices, sterilization, or condoms combined with a barrier method; male participants must also use condoms or avoid donating sperm.
Speak and understand Czech fluently.

Who cannot join the trial?

35 criteria

Having an acute (sudden) or chronic (long‑lasting) illness, or any health finding, that could affect the study’s purpose or the safety, comfort, how much of the drug reaches the bloodstream (bioavailability), or how the body processes the drug (pharmacokinetics).
Body temperature that is not between 35.7 °C and 36.9 °C when screened or when checking in.
Sitting blood pressure after at least 5 minutes of rest that is not between 105‑140 mmHg (systolic) or 70‑90 mmHg (diastolic), or a heart rate that is not between 50‑100 beats per minute during screening.
Existing stomach or intestinal problems, kidney disease (renal disease), or liver disease (hepatic disease) that could change the drug’s safety, how it is absorbed, or how the body handles it.
Any major abnormal test result, including a positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during screening.
Low red blood cell count (anemia) with hemoglobin below 120 g/L for women or 130 g/L for men at screening.
Positive pregnancy test (blood or urine) at screening, breastfeeding, or missing pregnancy test results.
Less than 45 days since finishing another clinical study before the first dose in this study.
Liver disease with high liver enzymes (ALT, AST, or GGT) that are three times or more above the normal upper limit during screening.
Blood sodium or potassium levels outside the normal range, unless the investigator decides they are not important for inclusion.
Creatine kinase (CK) level outside the normal range, unless the investigator decides it is not important for inclusion.
Use of any systemic medication that is known to change liver metabolism within 90 days before the first dose.
Impaired kidney function, defined as a creatinine clearance (MDRD) less than 1 mL/s.
Current or past muscle disorders (such as muscle toxicity, myopathy, or rhabdomyolysis), current muscle injury, or a family history of inherited muscle diseases.
History of angioedema (deep swelling of the skin or mucous membranes).
History or presence of a serious illness that could affect how the drug is absorbed, distributed, metabolized, or eliminated.
Current or past heart failure, high blood pressure, narrowing of the aortic or mitral heart valves, or thickened heart muscle (hypertrophic cardiomyopathy).
History of lactose intolerance, galactose intolerance, or glucose‑galactose malabsorption syndrome.
Current or past underactive thyroid (hypothyroidism).
Severe allergy or allergic reaction to the study drug, related drugs (such as ACE inhibitors or dihydropyridine derivatives), or any of the inactive ingredients (excipients).
Significant illness within 28 days before the first dose, including major surgery.
Serious mental illness or inability to cooperate with the study team.
Any prescription medication taken within 28 days before the first dose, except stable hormonal contraceptives or substitution therapy that has not changed dose for at least 90 days.
History of orthostatic hypotension (a drop in blood pressure when standing up) or occurrence during screening.
Abuse of drugs, alcohol (40 g or more of pure ethanol per day for men, 20 g or more for women), solvents, or caffeine.
Use of drugs that are toxic to major organs (for example, chloramphenicol, which can suppress bone marrow) within 90 days before the first dose.
COVID‑19 vaccination less than 14 days before screening or planning to receive a COVID‑19 vaccine during the study.
Hospitalization for COVID‑19 related reasons.
Positive COVID‑19 test (PCR or antigen) required for safety before entering the study.
Any over‑the‑counter medication, vitamin, herbal product (such as Saint John’s Wort), or food supplement taken 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‑penetrating treatment 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 alcohol test at screening or check‑in.
Positive urine cotinine test at screening (indicating recent nicotine use).

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

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Investigated drugs

Ramipril
is a medicine that belongs to a group called ACE inhibitors. It helps to relax blood vessels and lower blood pressure. In this study, it is one of the test drugs that is given alone and also together with other medicines to see if they affect each other’s behavior in the body.
Rosuvastatin
is a cholesterol‑lowering drug, known as a statin. It works by reducing the amount of “bad” cholesterol that the liver makes. In the trial, it is tested by itself and also when taken at the same time as the other test medicines to check for any interactions.
Heparin
is an anticoagulant that is given by injection into a vein. It helps prevent blood clots from forming. In this study, it is used as a background treatment, meaning it is given to all participants to keep blood clot risk low while the test medicines are being examined.
Amlodipine
is a medication that belongs to a class called calcium‑channel blockers. It relaxes and widens blood vessels, which helps lower blood pressure. Like the other test drugs, it is taken alone and also together with the other medicines to see if any drug‑drug interactions occur.

What is already known about the treatment

Ramipril
This medication is taken as an oral tablet taken by mouth. It is an approved drug widely used to treat high blood pressure, heart failure, and to protect the heart after a heart attack. It works by blocking the enzyme that creates angiotensin II, which relaxes blood vessels, and it belongs to the class of angiotensin‑converting‑enzyme (ACE) inhibitors.
Rosuvastatin
This drug is administered as a film‑coated oral tablet swallowed with water. It is a licensed treatment for lowering cholesterol and reducing the risk of heart disease. It inhibits the liver enzyme HMG‑CoA reductase, which lowers cholesterol production, and it is classified as a statin (HMG‑CoA reductase inhibitor).
Heparin sodium
This product is given as an intravenous solution injected directly into a vein. It is a well‑established anticoagulant used to prevent blood clots during surgery, dialysis, and other medical procedures. It enhances the activity of antithrombin, which disables clotting proteins like thrombin, and it belongs to the class of indirect thrombin inhibitors (anticoagulants).
Amlodipine
This medication comes as an oral tablet taken by mouth. It is an approved therapy for high blood pressure and chest pain (angina). It relaxes the smooth muscle in blood‑vessel walls by blocking calcium channels, lowering vascular resistance, and it is classified as a dihydropyridine calcium‑channel blocker.

Investigated diseases

Essential hypertension
a condition where blood pressure remains consistently higher than normal over long periods. It develops gradually as blood vessels become less flexible and the heart works harder. Over time the elevated pressure can increase strain on the heart and blood vessels. Early stages often have no obvious symptoms. Risk factors include age, diet, weight, and family history. Monitoring blood pressure helps track its progression.
Primary hypercholesterolemia
a disorder characterized by persistently high levels of cholesterol in the blood. It usually arises from genetic factors and lifestyle influences that affect cholesterol metabolism. Excess cholesterol can accumulate in artery walls, forming fatty deposits. As these deposits grow, arteries become narrower, reducing blood flow. The condition typically progresses silently for many years. Routine blood tests can detect rising cholesterol levels.
Deep vein thrombosis
formation of a blood clot within a deep vein, most commonly in the leg. It often starts with a small clot that can enlarge over time. The clot may cause swelling, pain, and redness in the affected limb. If the clot grows, it can partially or fully block blood flow in the vein. The condition can develop gradually, especially in individuals with limited mobility. Observing changes in leg appearance and sensation helps identify its progression.