Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Evaluation of bioequivalence of two products containing 50 mg dimenhydrinate: Dimenhydrinate 50 mg (Test) vs. Vomex A 50 mg Lösung zum Einnehmen im Beutel (Comparator). A monocentric, open, randomized, single dose, two-period, crossover trial in healthy volunteers

Researchers are conducting a study to compare two different medicines that both contain 50mg of dimenhydrinate. This is a common medicine often used to prevent or treat sickness and dizziness, for example, from motion sickness. The study wants to see if a newer version of the medicine works in the same way as an established one. They are giving a single dose of each medicine, at different times, to healthy adult volunteers. This type of study is called a 'bioequivalence' study and it's a standard step to ensure new medicines are just as effective and safe as existing ones. It focuses on how the body absorbs and uses the medicine, rather than treating a specific illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Hermes Pharma GmbH

Enrolment target

Start

11 Nov 2024

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

This study is comparing two different medicines that both contain 50mg of dimenhydrinate. You might know dimenhydrinate by brand names like Dramamine, and it's often used to help with feeling sick or dizzy, especially from motion sickness. The main goal of this study is to check if a new version of dimenhydrinate works in the same way as an existing one that's already used.

Think of it like comparing two different brands of a common painkiller – both have the same active ingredient, but this study confirms your body uses them in the same way. This is a crucial step for new medicines because it helps ensure that a new version will be just as effective and safe as the medicine it's being compared to. Because this type of study is about how the body handles the medicine, it involves healthy volunteers rather than people with a specific illness.

So, while dimenhydrinate can be used to treat things like motion sickness, this particular study isn't looking at treating any condition. Instead, it's about the very early stages of testing a medication to make sure it's chemically similar enough to an already approved one. This helps regulatory bodies ensure new medicines meet high standards before they become widely available.

Key takeaways

Compares two versions of dimenhydrinate medicine (for motion sickness).
Checks if a new version works the same way as an existing one.
Involves healthy adults aged 18 and over.
Participants take a single dose of each medicine at different times.
Mainly involves blood tests to see how the body handles the medicine.
Contributes to ensuring new versions of medicines are safe and effective.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part. Because the study involves healthy volunteers, you should not have any ongoing health problems.

The research team will need to check your general health to make sure it's safe for you to participate. This will likely involve a medical check-up and some tests to confirm you are in good health. They will provide all the detailed criteria.

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 able to attend the study site for multiple visits?
Are you comfortable with having regular blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of each of the two dimenhydrinate medicines, but not at the same time. These would be given on separate occasions, with a break in between. The study is a 'crossover' design, meaning you would try both medicines over two separate visits. After taking each medicine, you would likely stay at the study site for a period so doctors can take regular blood samples to see how your body processes the medicine. There might also be other checks, like measuring your heart rate and blood pressure, to monitor your well-being. The total length of your involvement, including both medication periods and follow-up, would be fully explained by the study team.

Potential risks and benefits

There isn't a direct health benefit for you from taking part, as this study is not treating an illness. However, by participating, you contribute to important medical research that ensures new medicines are safe and effective for others in the future. Potential risks might include common side effects of dimenhydrinate, like drowsiness, or discomfort from blood draws. The study team will explain all known risks and closely monitor your health throughout. You are free 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
Bulgaria

Common questions

What is dimenhydrinate?

Dimenhydrinate is a medicine commonly used to prevent and treat feeling sick or dizzy, especially from motion sickness.

Why is this study only for healthy people?

This study focuses on how the body handles the medication, not treating an illness. Using healthy people helps researchers clearly see the medicine's effects without other health conditions complicating the results.

Will I feel better after taking the medicine?

The study isn't designed to make you feel better or treat sickness. It's about how your body absorbs the drug. You might feel drowsy as a side effect.

Will I know which medicine I'm getting?

No, this study is 'open', meaning you and the researchers will know which medicine you're taking at each visit.

How long will I have to stay at the study site?

This will depend on how long it takes to collect the necessary blood samples after you take the medicine, and will be fully explained before you agree to take part.