Bio-equivalence of Rosuvastatin 10 mg
Rosuvastatin is a widely used medicine that helps lower cholesterol and protect against heart disease. This Phase 1 study is known as a bioequivalence trial. It aims to confirm that a new version of a 10 mg rosuvastatin tablet works identically in the body compared to the established brand. The trial is looking for healthy adult volunteers aged 18 and over. Participants will receive a dose of the medicine while doctors collect regular blood samples over a short period. This allows the research team to track how quickly and effectively the drug is absorbed and cleared by the body. Studies like this are an essential step before new, generic brands of existing medicines can be approved for use in the NHS. While taking part will not treat any illness, it helps make trusted treatments more accessible and cost-effective for everyone.
At a glance
What is this study about?
Rosuvastatin is a common medicine from a family of drugs called statins. Doctors regularly prescribe it to help people reduce high levels of cholesterol in their blood, which lowers the risk of heart attacks and strokes. Over time, different pharmaceutical companies produce their own versions of established medicines. Before a new version can be given to patients, researchers must prove that it is just as safe and reliable as the original.
This trial is called a 'bioequivalence' study. Rather than testing whether the medicine works to cure an illness, the goal is to measure how the human body handles it. Researchers compare the new 10 mg tablet directly against the standard version. They track how quickly the active ingredient enters the bloodstream, the highest level it reaches, and how long it stays in the body.
These studies are usually carried out with healthy volunteers in a controlled clinic setting. Because healthy participants do not have fluctuating medical conditions or take multiple other medicines, researchers can get clear, accurate measurements of how the tablet behaves on its own.
By taking part, volunteers support the scientific process that allows safe, generic medicines to reach pharmacy shelves. Generic medicines contain the same active ingredients as brand-name medicines but are often far less expensive, helping health services like the NHS save money while keeping patients healthy.
Key takeaways
- Tests a 10 mg generic rosuvastatin tablet against the standard version.
- Open to healthy adult volunteers aged 18 and older.
- Aims to prove the medicine is absorbed into the body in the exact same way.
- Involves health checks, taking study medicine, and regular blood tests.
- Participation is entirely voluntary with full medical supervision throughout.
Who may be eligible?
This trial is open to healthy men and women aged 18 and over. Because this is an early-stage study designed purely to measure how the body absorbs the medicine, researchers are specifically looking for people who do not have any major ongoing health conditions.
To be considered healthy for this trial, you should generally have normal blood pressure, a healthy heart, and properly functioning kidneys and liver. You will usually need to be free from long-term illnesses such as diabetes or heart disease, and not taking regular prescription medications that could interfere with the study results.
Before you can join, the clinic team will carry out a thorough health screening. This typically includes a physical examination, heart tracings (ECG), and standard blood and urine tests to make sure it is completely safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am at least 18 years old.
- I consider myself to be in good general health.
- I do not have any long-term liver, kidney, or heart conditions.
- I am not currently taking regular prescription medicines.
- I am comfortable having standard blood tests taken during clinic visits.
What does participation involve?
Taking part usually involves an initial screening visit followed by a short stay at a specialist clinical research unit. During the screening visit, the team will check your medical history, carry out basic health tests, and explain the study in detail. If you are eligible and decide to take part, you will be scheduled for the study period. You will take a single 10 mg rosuvastatin tablet with a glass of water. Over the next day or two, medical staff will collect small blood samples at set times to measure the medicine levels in your system. You will be monitored closely by doctors and nurses throughout your stay to ensure your safety and comfort. Afterward, there may be a brief follow-up phone call or clinic visit to check that you are feeling well. The entire study usually takes a few weeks from your first screening to your final check-up.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What does 'bioequivalence' mean?
It means proving that two different versions of the same medicine release the exact same amount of active ingredient into the bloodstream at the same speed.
Do I need to have high cholesterol to take part?
No. This study is specifically designed for healthy volunteers who do not have high cholesterol or heart problems.
Will taking part cure or prevent any health problems for me?
No. Because this is a short test in healthy adults, there is no direct health benefit to you, though it helps wider medical research.
Are there any side effects from a single dose of rosuvastatin?
Most people tolerate single doses very well, but occasional mild side effects include a slight headache, tummy upset, or feeling sick.
Can I change my mind after I sign up?
Yes. You can withdraw your consent and leave the study at any time, and you do not have to provide a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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