Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Study to Establish the Bioequivalence of Free Acid Tafamidis 61 mg Capsule and Tablet, and Evaluate the Safety and Tolerability of the 61 mg Tablet in Healthy Adults Under Fed Conditions

This research study is for healthy adults and is focused on a medicine called tafamidis. This medicine is used to treat a condition called transthyretin amyloidosis. The main goal is to compare a new tablet version of tafamidis (61 mg) with the existing capsule form (61 mg) to see if they both work in the same way in the body after you've eaten. This is important to make sure the new tablet is just as effective and safe as the capsule. The study will also look at how safe the new tablet is and how well people can tolerate it. By doing this, we can help provide more options for patients who might need this medication in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pfizer Inc.

Enrolment target

Start

11 Mar 2026

Transthyretin amyloidosis

What is this study about?

This study is about a medicine called tafamidis, which is used to treat a serious condition known as transthyretin amyloidosis. This condition happens when certain proteins build up in different parts of the body, which can cause problems with organs like the heart and nerves.

Currently, tafamidis is available as a capsule. This study is testing a new tablet form of the same medicine. The main reason for this study is to see if the new tablet (61 mg) works the same way in your body as the current capsule (61 mg). This is called a "bioequivalence" study. Think of it like comparing two different ways to deliver the same amount of a vitamin – you want to make sure both ways get the same amount of vitamin into your system. They will check this when healthy people take the medicine after eating.

Along with comparing how the medicine works, the study will also carefully check if the new tablet is safe to take and if people experience any side effects. This kind of study is an important early step in developing new medicines. If the new tablet is found to be just as effective and safe as the capsule, it could offer patients another way to take their medication, potentially making it easier for them.

Key takeaways

Tests a new tablet form of tafamidis medicine.
Compares the new tablet to the existing capsule.
Checks if both forms work the same way in the body.
Also assesses the safety and side effects of the new tablet.
Participants must be healthy adults (aged 18 and older).
Helps develop new treatment options for transthyretin amyloidosis.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate in this research.

Because this is a study comparing how a medicine works in the body, it's really important that participants are generally healthy. This helps the researchers understand the medicine's effects clearly without other health conditions getting in the way.

More specific details about your health, any medicines you take, and other factors would be discussed fully by the study team if you express interest. They will help you understand if you meet all the requirements.

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 healthy?
Are you available for study visits, potentially including overnight stays?
Are you comfortable with blood tests?
Are you able to take medication after a meal?

Answer every question to see your result.

What does participation involve?

While the exact details aren't fully described here, a study like this typically involves a few visits to a clinic over a short period. You would likely need to stay overnight or for several hours during each visit. During these visits, you'd be given either the tafamidis capsule or the new tablet, usually after eating a standardised meal. Researchers would then take blood samples at specific times to measure how the medicine is absorbed and leaves your body. You would also have regular health checks like blood pressure and heart rate measurements, and be asked about any side effects you experience. The total duration of your involvement could range from a few days to a few weeks, including follow-up phone calls or visits.

Potential risks and benefits

Potential benefits of taking part in this study are indirect; you would be helping medical science develop new options for patients with transthyretin amyloidosis. You might also receive free health check-ups during the study. As with any medication, there's always a possibility of side effects, ranging from mild to more serious, even though you are healthy. All known side effects would be fully explained before you agree to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Belgium

Common questions

What is 'bioequivalence'?

It means the study is checking if two different forms of a medicine (like a capsule and a tablet) deliver the same amount of the drug to your body at the same speed. It's about ensuring they work in the same way.

Why is this study only for healthy adults?

By studying healthy adults, researchers can get a clear picture of how the medicine acts in the body without other health conditions affecting the results. This is a common first step before testing in patients.

Will I get the medicine for transthyretin amyloidosis?

No, this study is about comparing how the medicine works, not treating a condition. Participants are healthy volunteers. You would receive either the test tablet or the existing capsule for a short period.

What is 'fed conditions'?

This means you will take the study medicine after you have eaten a meal. This helps researchers understand how food might affect how your body absorbs the medicine.

How long will I be in the study?

The exact duration isn't specified, but bioequivalence studies usually involve a few visits or study periods over days or weeks, including follow-up checks.