An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Maribavir Tablets 200 mg, manufactured by Sun Pharmaceutical Industries Limited, India with LIVTENCITY® (Maribavir) Coated Tablets 200 mg, manufactured by: Catalent CTS, LLC Kansas City, United States of America, packed by: Takeda Ireland Limited Bray, Ireland, imported by: Takeda Pharma Ltda. Highway SP 340 S/N, km 133.5 Jaguariúna Administrative Building -SP CNPJ 60.397.775/0001-74 SAC: 0800 - 7710345, in healthy adult, human subjects under fasting condition.
This study is looking at a new version of a medicine called Maribavir. Maribavir is an antiviral drug. The main goal is to see if this new version works in the same way as the original medicine already available. The study is comparing a Maribavir tablet made by Sun Pharmaceutical Industries Limited with the original LIVTENCITY® tablet. Healthy adult volunteers will take both medicines at different times, on an empty stomach. By carefully measuring how much of the medicine gets into the body from each tablet, researchers can be sure that the new version is just as effective and safe as the original. This type of study ensures patients get reliable medicines.
At a glance
What is this study about?
Imagine you have a favourite brand of crisps, and another company starts making their own version. This study is a bit like that, but for medicine. We're looking at a medicine called Maribavir, which is used to treat certain viral infections. There's an existing version of this medicine, and a new one has been developed.
The main aim of this study is to compare these two versions of Maribavir. We want to make sure that the new tablet works in exactly the same way as the original one when it's taken by people. This type of study is called a 'bioequivalence' study, which simply means we're checking if the two medicines are equal in how they act in the body.
Healthy adult volunteers will take a single dose of each medicine on an empty stomach, at different times. Researchers will then check how much of the medicine gets into their bloodstream and how long it stays there. This careful comparison helps doctors and pharmacists be confident that the new Maribavir tablet will be just as effective and safe for patients as the original, even though it might be made by a different manufacturer.
Key takeaways
- This study compares two versions of the antiviral medicine, Maribavir.
- The main goal is to confirm they work the same way in the body.
- It's for healthy adults aged 18 and over.
- Participants will take each medicine once, on an empty stomach.
- Blood samples will be taken to measure medicine levels.
- This helps ensure new medicines are reliable and safe.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old to take part. There's no upper age limit, as long as you are generally in good health.
Both men and women are welcome to participate in this study. The main requirement is that you are healthy, meaning you don't have any significant ongoing medical conditions that could affect how your body handles the medicine.
Before you can join, a medical team will carry out some checks to make sure this study is right for you and that you meet all the health requirements. They will explain everything clearly.
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 at least 18 years old?
- Are you generally in good health?
- Do you have any major ongoing medical conditions?
- Are you comfortable with regular blood tests?
- Are you able to follow specific fasting instructions?
What does participation involve?
If you decide to take part in this study, you'll be asked to visit a clinic for a few days. You will receive a single dose of one version of the Maribavir medicine, and then, after a break, you'll receive a single dose of the other version. This is done on an empty stomach to ensure consistent results.
During your visits, medical staff will take blood samples at specific times after you've taken the medicine. These samples help them measure how much of the medicine is in your body. You'll also have regular check-ups to monitor your general health.
After each dose, you'll be observed for a period. The total time you'd spend actively participating in the study, including all visits and follow-ups, would be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is Maribavir used for?
Maribavir is an antiviral medicine that treats certain types of viral infections.
Why are you comparing two different tablets?
We are checking if a new version of the medicine works exactly the same in the body as the original, to make sure it's just as effective and safe.
Will I have to stay at the clinic?
You will need to attend the clinic for specific visits, and you may need to stay for a period after taking the medicine for observation.
Will I get paid for being in the study?
Most studies like this offer payment for your time and inconvenience. This will be discussed with you before you agree to take part.
What does 'fasting condition' mean?
It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before and after taking the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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