Randomised, bioequivalence clinical trial of ezetimibe/atorvastatin 10 mg/40 mg tablets versus ezetimibe/atorvastatin 10 mg/40 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design
This research study looked at two different versions of a combination drug containing ezetimibe and atorvastatin, which are used to treat high cholesterol. We gave a single dose of each version to healthy volunteers to see how their bodies absorbed the medication. The main aim was to check if a new version (film-coated tablet) was 'bioequivalent' to an existing one. Bioequivalence means the new version works in essentially the same way and delivers similar amounts of the drug to the bloodstream at similar speeds. This kind of study is important to make sure that when new versions of medicines become available, they are just as safe and effective as the original ones for patients.
At a glance
What is this study about?
This clinical trial is designed to compare two different types of tablets that contain the same two medicines: ezetimibe and atorvastatin. These medicines are commonly used together to help lower cholesterol levels in the blood, which is important for heart health. One tablet is a standard version, and the other is a 'film-coated' version. The study wants to find out if the body absorbs these two versions in the same way after someone takes a single dose.
Imagine you have two slightly different brands of the same painkiller. This study is like checking if both brands deliver the medicine to your body at the same speed and in the same amount. This is called a 'bioequivalence' study. It's a very early-stage trial, often called a Phase I study, because it focuses on how the drug behaves in the body rather than treating a specific illness. It's important for ensuring new versions of existing medicines work just as well as the original ones.
The main goal is to measure how much of each medicine (ezetimibe and atorvastatin) gets into the bloodstream and how quickly. Researchers will look at things like the highest level of the drug in the blood and the total amount absorbed over a certain time. This helps confirm that any new or slightly changed tablet works just as effectively and safely as the original medication.
Key takeaways
- This study compares two tablet forms of a cholesterol-lowering drug.
- It aims to see if a new version works just like the original (bioequivalence).
- Healthy volunteers are needed to participate.
- Participation involves taking single doses and having blood samples taken.
- This is an early-stage study to ensure new medicines are safe and effective.
Who may be eligible?
This study is looking for healthy adult volunteers. 'Healthy' means you don't have any major ongoing medical conditions that could affect how your body handles the medication being studied. You should also not be taking any other medicines that could interfere with the study drugs.
To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, but you would still need to meet all the other health requirements.
Both men and women are welcome to take part in this study, provided they meet all the other health criteria. Your doctors will do a thorough health check to make sure it's safe for you to participate.
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?
- Do you consider yourself generally healthy?
- Are you able to visit a clinic for several hours or overnight stays?
- Are you comfortable having regular blood samples taken?
- Are you able to stop taking any other medications for the study period, if required?
What does participation involve?
If you decide to take part in this study, you will be given a single dose of one of the two study medications. This type of study usually involves several visits to a clinic, often including overnight stays, so that healthcare professionals can closely monitor you and take blood samples at specific times after you've taken the medicine. They will measure the levels of the drugs in your blood over a period, usually for a few days.
Because this is a 'crossover' study, you will likely take both versions of the medication at different times, with a washout period in between. This means you’d have one study experience, then a break where you take no study medication, and then another study experience where you take the other version. The total duration of your involvement, including all visits and the break, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means checking if two versions of the same medicine deliver the drug to your body in essentially the same way and amount, so they work just as well.
Why study healthy volunteers?
Using healthy volunteers helps researchers understand how the drug is absorbed and processed by the body without interference from existing illnesses or other medications.
What is ezetimibe/atorvastatin used for?
This combination medication is typically used to help lower high cholesterol levels in the blood, which is important for preventing heart disease.
Will I get both medications?
Yes, in this type of study, you will likely receive both versions of the medication, but at different times, to allow for a fair comparison in the same person.
How long will my blood be taken?
Blood samples are usually taken for several hours or even a few days after you take the medicine to track how it moves through your body.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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