Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Open-label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, study to assess the bioequivalence between the test product Betahistine dihydrochloride 24 mg tablets from Esperante Development BV and reference product Betaserc® 24 mg tablets.

This study is looking at a new version of a medication called betahistine. Betahistine is often used to treat conditions like Meniere's disease, which affects balance and hearing. The main goal is to check if this new betahistine tablet (24 mg) works in the same way as an established one already available. This is called a 'bioequivalence' study. Participants will take both types of tablets at different times, always on an empty stomach, so scientists can compare how much of the medicine gets into the bloodstream and how quickly. This helps ensure new medications are just as safe and effective as existing treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Esperante Development B.V.

Enrolment target

Start

08 Oct 2025

Bioequivalence study under fasting conditions

What is this study about?

This research is a special type of study called a 'bioequivalence' trial. Its main purpose is to compare two different versions of the same medicine: a new betahistine tablet and an existing betahistine tablet (Betaserc®). Betahistine is a medicine commonly prescribed for conditions like Meniere's disease, which can cause dizziness, ringing in the ears (tinnitus), and hearing loss.

Think of it like comparing two brands of paracetamol. Even though they contain the same active ingredient, scientists need to make sure they both deliver the medicine to your body in the same way and at the same rate. This study aims to do the same for betahistine. By confirming that the new tablet works just like the established one, doctors can be confident that patients will get the same treatment benefits, regardless of which version they receive.

This kind of study is really important for bringing new medicines to the market confidently. It helps ensure that new, potentially more affordable, or more accessible versions of medicines are just as effective and safe as the ones we already use. It's a foundational step to make sure patients continue to receive high-quality treatment.

Key takeaways

This study compares a new betahistine tablet with an existing one.
It aims to ensure new medicines work just as well as established ones.
You'll take both versions of the medicine, always on an empty stomach.
Blood samples will be taken to see how the medicine works in your body.
It's open to adults aged 18 and over, generally in good health.
Your safety and well-being will be carefully monitored throughout.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Importantly, this is a healthy volunteer study. This means that generally, people taking part should be in good overall health and not have any serious medical conditions that could affect how their body absorbs or processes medication. Doctors leading the study will review your health carefully.

Further checks will be made to ensure you fit all the requirements for taking part safely. This includes looking at any other medicines you might be taking, your medical history, and whether you have any allergies or other health concerns. These are all to protect your safety and get accurate results for the study.

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 follow specific instructions, like fasting?
Are you comfortable with having blood samples taken regularly?
Are you able to attend several study visits at a clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive both the new betahistine tablet and the existing betahistine tablet at different times. The study is designed in a 'crossover' way, which means you'll try each product. You'll switch between the two products over two different periods of time. Everything will be done under 'fasting conditions', meaning you'll need to avoid food and drink (except water) for a certain period before and after taking the study medicine.

During each study period, you will spend time at a clinic – usually for a day or overnight stay – where your health will be monitored, and blood samples will be taken regularly. These blood samples help scientists measure how much of the medicine gets into your bloodstream and how long it stays there. You'll then have a break (washout period) before starting the second treatment period with the other betahistine tablet, repeating similar visits and checks. The total duration of your involvement, including all visits and breaks, will be explained fully by the study team.

Potential risks and benefits

Participating in research always involves potential benefits and risks. A potential benefit of this study is contributing to the development of new medicines and helping ensure that patients continue to receive effective treatments. As this is a healthy volunteer study, you would likely receive payment for your time and contribution. Potential risks could include mild side effects from the medication, discomfort from blood draws, or the inconvenience of the study visits. All potential risks will be thoroughly explained, and your safety will be closely monitored by medical professionals throughout the study. You have the right to withdraw from the study at any time, for any reason, without 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
Czechia

Common questions

What is betahistine used for?

Betahistine is a medicine often prescribed to help treat symptoms of Meniere's disease, such as dizziness, spinning sensations (vertigo), ringing in the ears (tinnitus), and hearing loss.

What does 'bioequivalence' mean?

Bioequivalence means that two medicines, even if they're made by different companies, deliver the same active ingredient to your body in the same way and at the same rate. This ensures they will work similarly.

Will I have to stay overnight for the study?

It's possible you might need to stay overnight at a clinic for some parts of the study, especially during the periods when you take the medication and blood samples are collected. The study team will confirm the exact schedule.

Why do I need to fast before taking the medicine?

Fasting means you can't eat or drink (except water) for a certain time. This is done so researchers can see how the medicine works in your body without food affecting its absorption, ensuring consistent and accurate results for comparison.

Will I know which medicine I'm getting?

Yes, in this type of study ('open-label'), you will know which betahistine tablet (the new one or the existing one) you are taking at each stage.