Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Safety and tolerability of medicated chewing gum with sodium alginate, calcium carbonate and sodium bicarbonate.

This research is investigating a new type of chewing gum. It contains three ingredients you might recognise: sodium alginate, calcium carbonate, and sodium bicarbonate. The main goal of this study is to see if this chewing gum is safe for people to use and if they have any problems or side effects when they chew it. This is a very early step in testing the gum, and it involves healthy volunteers, meaning people who don't have any specific medical conditions. By understanding how the body reacts to these ingredients in a chewing gum format, researchers can decide if further studies are warranted. This type of study is called 'Human Pharmacology' or 'Phase I', which means it's one of the first times it's being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Laboratorios Liconsa S.A.

Enrolment target

Start

02 Feb 2026

No medical condition.

What is this study about?

Imagine a new chewing gum that contains some common ingredients – sodium alginate, calcium carbonate, and sodium bicarbonate. You might have heard of these before; for example, calcium carbonate is often found in antacids to help with indigestion. This study is designed to answer a very important question: Is this new chewing gum safe for people to use, and can they use it without experiencing uncomfortable side effects? This is the very first step in checking if a new product works well, even before it's considered for any specific health conditions.

This kind of study is called a 'Human Pharmacology' study, or sometimes 'Phase I'. It's like a first test flight for an aeroplane – it’s done very carefully with a small number of people to make sure everything is working as it should and that it's safe. In this case, the 'people' are healthy volunteers, meaning individuals who don't have any particular illnesses or medical problems that might affect how their body reacts to the chewing gum.

The main aim isn't to treat any specific illness, but simply to gather information on how the chewing gum behaves in the body and if it causes any unexpected reactions. This crucial information helps researchers decide if it's sensible to continue testing the chewing gum in more advanced studies. Think of it as laying the groundwork for potential future uses, all starting with ensuring safety and ease of use.

Key takeaways

This study tests a new chewing gum for safety and tolerability.
It uses common ingredients: sodium alginate, calcium carbonate, and sodium bicarbonate.
It's a 'Phase I' study, meaning it's an initial safety check in healthy adults.
The study is not for treating any medical conditions.
Participants must be at least 18 years old.
Both men and women can participate.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults might also be able to join, as long as they are generally healthy.

Both men and women are welcome to participate. The most important thing is that you don't have any current medical conditions that could make taking part unsafe or affect the study's results. Because this is a safety study, researchers need to be sure that any effects seen are due to the chewing gum and not due to existing health issues.

More specific details about health checks, medications you might be taking, or other factors would be discussed with the study team if you express interest. This initial set of guidelines helps them find the right people for this early-stage safety testing.

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 not currently part of another clinical trial?
Are you comfortable with the idea of chewing an experimental gum?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be asked to chew the special gum they are testing. The study team will explain exactly when and for how long you need to chew it. You might have a few visits to the clinic or study centre so the researchers can check on your health and see how you're reacting to the gum. These visits might involve things like talking about how you feel, simple check-ups, and possibly giving samples (like blood or urine) to see how your body is processing the ingredients. All procedures will be explained in detail. The total length of the study for each participant will be clearly outlined by the research team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is helping science advance our understanding of how new products affect the body, which could ultimately lead to new options for people in the future. You might also receive a health check-up. The main potential risks generally involve minor side effects from the chewing gum, such as an upset stomach or a strange taste, or discomfort from any assessments like blood tests. All known risks will be fully explained before you agree to take part. Remember, you 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.

—
Unverified
Portugal

Common questions

What is sodium alginate, calcium carbonate, and sodium bicarbonate?

These are common substances. Sodium alginate comes from seaweed, calcium carbonate is often found in antacids, and sodium bicarbonate is baking soda. They are often used in food and medicines.

Why is this chewing gum being tested?

It's being tested to make sure it's safe for people to use and that most people can tolerate it without too many uncomfortable side effects. This is a very early but important safety check.

Will this chewing gum treat a medical condition?

No, this study is not looking at treating any conditions. It's only focused on whether the chewing gum is safe and well-tolerated in healthy people.

What is a 'Human Pharmacology (Phase I)' study?

It's one of the first times a new product is tested in a small group of healthy people. The main goal is to check for safety and how the body handles the product.

Do I have to take part if I'm interested?

No, expressing interest doesn't mean you have to join. You'll receive full information and can decide if it's right for you, and you can withdraw at any time.