Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.

This study is looking at a new version of the medicine valacyclovir, which comes as a liquid. This medicine helps treat infections like cold sores and shingles. We want to see how well the new liquid valacyclovir is absorbed into the bloodstream compared to the liquid version that doctors usually mix up. The study will also check for any side effects and find out if taking the new liquid with or without food changes how much of the medicine gets into the body. This is a common type of study done early on to make sure new medicines work as expected and are safe.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Dermax

Enrolment target

Start

20 Jul 2023

Not applicable (submitted trial is a bioequivalence study in healthy subjects)

What is this study about?

This study is a research project focusing on a medicine called valacyclovir, which is often used to treat viral infections like cold sores, shingles, and genital herpes. Currently, if you need a liquid version of valacyclovir, your pharmacist usually has to prepare it specially. This study is testing a new, pre-prepared liquid form of the medicine that could be easier to use.

The main goal is to find out if this new liquid valacyclovir is absorbed by your body in the same way as the current liquid version made by a pharmacist. This is important because the way a medicine is absorbed affects how well it works. Scientists will measure how much of the medicine gets into your blood and how quickly, to ensure the new liquid form works just as effectively and safely.

The study will also investigate if eating food affects how your body absorbs this new liquid valacyclovir. This information is very helpful for doctors and patients, as it helps them know the best way to take the medicine – whether it's better on an empty stomach or with a meal, for example.

Key takeaways

This study is testing a new, pre-mixed liquid form of valacyclovir medicine.
It aims to see if the new liquid works the same as the current pharmacist-prepared liquid.
The study also checks if food affects how the new liquid medicine is absorbed.
It involves healthy adult volunteers aged 18 and over.
Your contribution helps understand how new medicines work for everyone.

Who may be eligible?

This study is looking for healthy adult volunteers. You need to be between 18 years old and any older age, as long as you are generally healthy.

Both men and women can take part in this study.

Because this is a study about how medicines are absorbed in healthy people, you won't be able to join if you have certain health conditions or are taking medications that might affect the 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 multiple study visits?
Are you comfortable with having blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a short period. You will visit the study site multiple times. During these visits, you will be given different versions of the valacyclovir medication (either the new liquid or the standard liquid). After taking the medicine, blood samples will be collected at various times over several hours to measure how much of the drug is in your body. You will also have regular health checks to make sure you are well and to record any side effects. Each time you take the medicine, there will be a break period before you take the next one. The total time you're actively involved in the study, including all visits and breaks, will be explained by the study team.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health, as its main purpose is to gather information about a new medication. However, you will be contributing to medical knowledge that could help future patients. Like all medicines, valacyclovir can have side effects, and you will be closely monitored for these. There's also the discomfort of blood draws. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it won't affect any future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Czechia

Common questions

What is Valacyclovir used for?

Valacyclovir is a medicine used to treat viral infections like cold sores, shingles (a type of chickenpox reactivation), and genital herpes.

Why is this study being done in healthy people?

Studies like this are often done in healthy volunteers first to see how a new medicine is safely absorbed and processed by the body without the complications of an existing illness.

Will I receive treatment for a specific illness in this study?

No, this study is not for treating an illness. Its purpose is to test how a new liquid form of valacyclovir works in healthy people.

What does 'pharmacokinetic' mean in simple terms?

It means the study will look at what your body does to the medicine – how it's absorbed, distributed, broken down, and leaves your body.

What if I experience side effects?

The study team will monitor you closely for any side effects, and you should tell them immediately if you feel unwell or notice anything unusual.