Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg (Haleon) to assess Bioequivalence with Alvedon 500 mg Film-Coated Tablet (Haleon, Sweden) and Panadol 500 mg Film-Coated Tablet (Haleon, Australia) in Healthy Adult Subjects Under Fasting Conditions

This study looked at a new paracetamol tablet that dissolves in your mouth, called an 'orodispersible' tablet. It compared how quickly and effectively your body absorbed this new tablet versus two well-known standard paracetamol tablets (Alvedon and Panadol). The main goal was to see if the new dissolvable tablet worked in a similar way to the existing ones. This type of research, called a 'bioequivalence study,' helps ensure that a new form of a medicine delivers the same amount of the active ingredient into your bloodstream as an established one, meaning it should have the same effect. Researchers gave a single dose of each paracetamol type to healthy adult volunteers on different days to make this comparison.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Haleon CH SARL

Enrolment target

Start

10 Dec 2024

Healthy volunteers therapeutic indication not studied

What is this study about?

Imagine you're trying a new type of paracetamol that just melts in your mouth without needing water. This study is all about making sure that new dissolvable tablet works just as well as the paracetamol tablets you might already be familiar with, like Panadol.

Researchers wanted to see if your body absorbs the new dissolvable paracetamol in the same way – meaning at a similar speed and in a similar amount – as it absorbs the regular, film-coated tablets. This is really important because if your body absorbs the medicine differently, it might not work as expected. So, this study ensures that the new dissolvable paracetamol delivers the same amount of pain relief as the standard tablets.

This kind of study is called a 'bioequivalence study.' It's a common and necessary step when a company wants to introduce a new form of an existing medicine. It helps ensure that while the new tablet might feel different to take, its medical effect on your body is just the same as the trusted versions.

Key takeaways

This study compared a new fast-dissolving paracetamol tablet with standard paracetamol tablets.
The goal was to make sure the new tablet works the same way in your body as established ones.
It involved healthy adult volunteers taking a single dose of each paracetamol type.
Blood samples were taken to see how the paracetamol was absorbed.
Known as a 'bioequivalence study,' it's a standard step for new medicine formats.

Who may be eligible?

This study was looking for healthy adults to take part. This means people who don't have any ongoing health problems that could affect how their body handles medicines.

Participants needed to be at least 18 years old. There wasn't an upper age limit mentioned, so older adults could also be considered if they were otherwise healthy.

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 generally healthy with no ongoing medical conditions?
Are you 18 years old or older?
Are you able to attend clinic visits for blood draws?
Are you comfortable taking a single dose of paracetamol?

Answer every question to see your result.

What does participation involve?

If you had taken part in this study, you would have received a single dose of one type of paracetamol on a specific day, then a different type on another day, and finally the third type on a third day. These days would have been separated by a break to allow the previous dose to leave your system.

On each study day, you would have had blood samples taken regularly over several hours after taking the medicine. This helps researchers measure how much paracetamol is in your bloodstream over time. You would also have had some general health checks to make sure you remained well throughout the study. The total duration of your involvement, including all visits and follow-ups, would have been explained in detail.

Potential risks and benefits

The main benefit of taking part in a study like this is contributing to medical science and helping to make sure new medicines are safe and effective for everyone. You might also receive some compensation for your time and travel. Potential risks are usually small, especially in studies involving well-known medicines like paracetamol in healthy people. You might experience minor discomfort from blood draws, or very rarely, side effects from paracetamol, though it was given at a standard dose. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is 'paracetamol'?

Paracetamol is a common medicine used to relieve pain and reduce fever. You might know it as Panadol or by its generic name.

What does 'bioequivalence' mean?

It means researchers are checking if a new version of a medicine works in your body in the exact same way as an existing, trusted version. It's about ensuring consistency.

What is an 'orodispersible tablet'?

This is a type of tablet that dissolves quickly in your mouth, usually without needing any water to swallow it. It's often helpful for people who have difficulty swallowing pills.

Why do studies like this use 'healthy volunteers'?

Using healthy volunteers helps researchers understand how the medicine behaves in the body without other health conditions interfering. This makes the results clearer.

Will this new paracetamol be better than regular tablets?

The aim of this study is not to make it 'better' but to confirm it's 'the same' in terms of how your body uses it. The main difference would be how easy it is to take.