Randomised, crossover bioequivalence clinical trial of rosuvastatin/ezetimibe 20 mg/ 10 mg film-coated tablets versus rosuvastatin/ezetimibe 20 mg/ 10 mg hard capsules, after a single oral dose administration to healthy volunteers under fasting conditions.
This study is a research project looking at two different forms of a combined medicine called rosuvastatin/ezetimibe. This medicine is often used to help manage cholesterol levels. We're interested in comparing a new film-coated tablet against an existing hard capsule, both containing the same 20mg/10mg dose. Healthy volunteers will take one dose of each form on different occasions, on an empty stomach. The main aim is to see if the body absorbs and uses the active ingredients (rosuvastatin and ezetimibe) in the same way from both the tablet and the capsule. This type of study, called a bioequivalence study, helps ensure that new versions of medicines are just as effective and safe as the original ones.
At a glance
What is this study about?
This research study is designed to compare two different ways that a common medicine for cholesterol is packaged. The medicine contains two active ingredients: rosuvastatin and ezetimibe. These are combined to help treat high cholesterol. One version is a film-coated tablet, and the other is a hard capsule.
The main goal of this study is to see if these two forms of the medicine deliver the active ingredients (rosuvastatin and total ezetimibe) into the body in the same way and at the same rate. This is called 'bioequivalence'. It's important to do these checks so that if a new version of a medicine comes out, doctors and patients can be confident it will work just as well as the original.
Healthy volunteers will take a single dose of each form of the medicine (tablet and capsule) on separate occasions. Researchers will then take blood samples over time to measure how much of the medicine gets into the bloodstream and how long it stays there. This helps us understand if both forms are absorbed equally in the body, ensuring that a patient gets the same effect regardless of whether they take the tablet or the capsule.
Key takeaways
- This study compares two forms (tablet vs. capsule) of a cholesterol medicine.
- It checks if both forms are absorbed equally by the body.
- Only healthy adult volunteers can take part.
- Participation involves taking single doses and giving blood samples.
- The study helps ensure new medicines are safe and effective.
Who may be eligible?
This study is looking for healthy volunteers to take part. To be eligible, you need to be an adult, aged 18 years or older. There is no upper age limit for participants.
Both men and women are welcome to take part in this study. The most important thing is that you are in good general health, as confirmed by the study doctors, because the study aims to understand how the medicine behaves in a typical healthy person's body.
More specific health checks will be done by the study team to make sure it's safe for you to participate and that you meet all the detailed requirements for the study. For instance, they'll check you don't have any medical conditions or aren't taking any other medicines that could affect the study results.
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.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you able to attend appointments at a clinic?
- Are you comfortable having blood samples taken?
What does participation involve?
If you decide to take part, you would receive a single dose of the tablet form on one occasion, and a single dose of the capsule form on another occasion. These would typically happen a few weeks apart. You would be asked to take the medication on an empty stomach.
Each time you take the medication, you would visit the study centre. Over the next day or so, the study team would take several blood samples to measure how the medicine moves through your body. There will also be health checks, likely including physical exams and reviewing your medical history, to make sure you are suitable and stay well. You would be followed until the medicine has cleared your system. The total duration of your participation, including all visits and follow-up, would be confirmed by the study team.
Potential risks and benefits
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Common questions
What is rosuvastatin/ezetimibe used for?
It's a medicine often prescribed to help lower high cholesterol levels in the blood.
Why are you comparing a tablet and a capsule?
We want to make sure that a new tablet version of the medicine works just as well as the existing capsule version, by checking how the body absorbs them.
Will I receive an active drug or a dummy pill (placebo)?
You will receive the active rosuvastatin/ezetimibe medicine, both as a tablet and a capsule, at different times.
Do I need to be ill to take part?
No, this study is specifically looking for healthy volunteers, not people with health conditions.
Will I have to stay overnight?
The study design will determine if any overnight stays are needed. This will be fully explained to you before you agree to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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