Randomised, bioequivalence clinical trial of ezetimibe/atorvastatin 10 mg/80 mg tablets versus ezetimibe/atorvastatin 10 mg/80 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.
This study is comparing two types of tablets that contain the medicines ezetimibe and atorvastatin. These medicines are used to lower cholesterol. Researchers want to see if a new generic tablet is absorbed by the body in the same way as an already approved tablet. Healthy adult volunteers will take a single dose of each tablet at different times to see how much of the medicine gets into their bloodstream and how quickly. This helps ensure that the new generic version works just as well and is as safe as the original.
At a glance
What is this study about?
This study is all about making sure that new versions of medicines are just as good as the original ones. Many people take a combination of two medicines, ezetimibe and atorvastatin, to help lower their cholesterol levels and keep their hearts healthy. When a company wants to make a new, often cheaper, version of an existing medicine, they need to prove that it works in the same way. This is called a 'bioequivalence' study.
In this particular study, researchers are comparing two different tablets that contain ezetimibe and atorvastatin. One is an existing tablet, and the other is a new version. The main goal is to check if these two tablets deliver the active ingredients to your body at the same speed and in the same amounts. This is important because it ensures that patients will get the same benefits from the new tablet as they would from the original.
Healthy adult volunteers are chosen for this type of early-stage study because their bodies generally respond in a predictable way. By giving them a single dose of each tablet and then carefully measuring the levels of medication in their blood over time, the researchers can determine if the new tablet is just as effective and safe as the one already available.
Key takeaways
- This study compares two versions of a cholesterol-lowering medicine.
- It aims to ensure new generic medicines work the same as existing ones.
- Healthy adult volunteers are needed.
- Participation involves clinic visits, blood tests, and taking study medication.
- You'll be carefully monitored throughout the study.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part. Being 'healthy' means you don't have any major ongoing illnesses or medical conditions that could affect the study results or put your health at risk.
The researchers will check your overall health carefully to make sure it's safe for you to participate. This usually involves a medical check-up, blood tests, and reviewing your medical history. They want to make sure you are in good general health before you take any study medication.
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 healthy, without major ongoing medical conditions?
- Are you able to attend several clinic appointments?
- Are you comfortable with having regular blood samples taken?
- Are you willing to follow specific instructions, like fasting before visits?
What does participation involve?
If you decide to take part, you will be considered a 'healthy volunteer'. The study involves taking a single dose of two different types of tablets at separate times. These will be given in a 'crossover' design, meaning you will take one type of tablet, and then after a break, you'll take the other type.
Expect to visit the study clinic multiple times. During these visits, blood samples will be taken frequently to measure how much of the medicine is in your body and how quickly it's absorbed. You might also have general health checks like measurements of your heart rate and blood pressure. You will need to fast (not eat) for a certain period before taking the medication and for a few hours afterwards. The study team will explain the exact schedule, including the length of each visit and the breaks between taking the different medicines. The total duration of your participation will depend on the detailed schedule of visits and follow-up tests.
Potential risks and benefits
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Common questions
What kind of medicine are they testing?
They are testing two types of tablets that contain common cholesterol-lowering medicines called ezetimibe and atorvastatin.
Why are they doing this study?
They want to make sure a new version of the medicine works just as well and is absorbed the same way as an already approved one.
Who can join the study?
Healthy adults aged 18 and over, both men and women, can take part.
Will I have to stay at the clinic?
You will need to attend multiple visits, likely for several hours at a time, and will need to fast before certain visits.
What will I have to do if I join?
You'll take single doses of the medicines at different times, and blood samples will be taken frequently to see how your body uses the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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