An open label, randomized, two-period, two-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to European sourced Valtrex® Tablets in normal, healthy subjects under fasting conditions.
This study is looking at a new liquid version of a medicine called valacyclovir. Valacyclovir is used to treat certain viral infections. We are comparing this new liquid medicine with the tablet version that is already sold in Europe. Our main goal is to find out if your body absorbs the new liquid medicine in the same way as the tablet. We also want to check if the new liquid form is safe when given to healthy adults. This type of study helps make sure new medicines work as expected before they are widely used.
At a glance
What is this study about?
Imagine you have a new flavour of your favourite drink. Even though it's still your favourite drink, you might wonder if it gives you the same boost or works in your body in the same way. This study is a bit like that, but for medicine.
The medicine we're looking at is called valacyclovir. It's used to treat viral infections like cold sores, shingles, and genital herpes. Currently, it's mostly available as a tablet. But sometimes, people find it difficult to swallow tablets, or they might prefer a liquid medicine. So, scientists have developed a liquid version of valacyclovir.
This study is designed to see if this new liquid valacyclovir medicine (what we call 'oral suspension') works in your body in the same way as the current valacyclovir tablets, specifically those available in Europe (known by the brand name Valtrex®). We'll be looking at how quickly and how much of the medicine gets into your bloodstream. This is really important to make sure that if patients take the liquid form, they get the same amount of medicine working in their body as they would with the tablet form. We'll also be carefully checking for any side effects to make sure the new liquid medicine is safe.
Key takeaways
- This study compares a new liquid valacyclovir with the existing tablet version.
- It aims to see if both forms work similarly in your body and are safe.
- Only healthy adults aged 18 and over can participate.
- You will receive both the liquid and tablet medicine at different times.
- Your involvement helps ensure new medicines are effective and safe for everyone.
Who may be eligible?
This study is for generally healthy adults. You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but you would still need to be considered generally healthy by the study doctors.
Both men and women are welcome to participate in this study. The main idea is to include people who don't have any major health problems, as this helps us understand how the medicine works in a typical, healthy person before considering people with existing medical conditions.
To be considered healthy, the study doctors will check your medical history, do some physical exams, and run some tests to make sure you can safely 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.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend several clinic visits?
- Are you happy to have blood samples taken regularly?
- Are you comfortable with being asked to fast (not eat) sometimes?
What does participation involve?
If you decide to join this study, you will likely visit the clinic several times. You will be given both the new liquid valacyclovir and the existing valacyclovir tablets at different times, with a break in between. This allows the researchers to compare how your body handles each one.
On the days you take the medicine, you'll need to be at the clinic, usually for several hours. This is because we need to take several blood samples over time to measure how much medicine is in your bloodstream. You'll be asked not to eat for a certain time before taking the medicine (we call this 'fasting') and possibly for a few hours afterwards. You'll also have regular check-ups, including physical examinations and other tests, to ensure you remain healthy throughout the study. The total duration of your involvement, including all visits and follow-up, will be explained in detail.
Potential risks and benefits
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Common questions
What is valacyclovir?
Valacyclovir is a medicine used to treat viral infections like cold sores, shingles, and genital herpes.
Why is this study important?
It helps us compare a new liquid form of valacyclovir with the existing tablet form to make sure they work similarly and are safe for patients.
Who can take part in this study?
Generally healthy adults aged 18 and over, both men and women, who meet specific health requirements.
Will I take both the liquid and tablet medicine?
Yes, you will take both forms of the medicine at different times during the study so we can compare them.
What does 'fasting conditions' mean?
It means you won't be allowed to eat for a certain period before and possibly after taking the medicine, to make sure food doesn't affect how your body absorbs it.
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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