Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, randomized, single dose, two-sequence, two-treatment, four-period, fully replicate, cross-over pharmacokinetic study comparing Alverine citrate/Simeticone 60 mg/300 mg soft capsules to Meteospasmyl 60 mg/300 mg soft capsules in healthy male and female subjects under fed conditions.

This research study is looking at two types of medications that contain alverine citrate and simeticone, which are used to help with symptoms like bloating and gas. The medications are called 'Alverine citrate/Simeticone 60 mg/300 mg soft capsules' and 'Meteospasmyl 60 mg/300 mg soft capsules'. We want to find out if these two medications are absorbed and processed by the body in the same way when taken after eating. This is important to make sure that different versions of the same medicine work equally well. We are doing this in healthy adult volunteers, both men and women, to understand how these medications behave in the body without other health conditions affecting the results.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Zaklady Farmaceutyczne Polpharma S.A.

Enrolment target

Start

13 Sep 2024

Not applicable (submitted trial is a bioavailability study in healthy subjects)

What is this study about?

This study is a research project designed to compare two specific medications that help with uncomfortable symptoms like bloating and trapped wind. Both medicines contain the same active ingredients: alverine citrate and simeticone. One is called 'Alverine citrate/Simeticone', and the other is 'Meteospasmyl'. We want to understand if these two medications are absorbed into the bloodstream and broken down by the body in a very similar way when people take them after eating food. This type of research is an important early step to ensure that different versions of a medicine are equally effective and safe.

The main goal is to check if these two medications are 'bioequivalent'. This means we're looking to see if your body uses them in much the same way. This is a common and necessary part of developing medicines, especially if a new version of an existing medicine is being made. By showing they are bioequivalent, it helps ensure that patients can expect the same results from either medicine.

Because we want to understand how the body handles these medications without other health problems getting in the way, we're asking healthy volunteers to take part. This helps us get a clear picture of how the drugs behave in a typical person.

Key takeaways

Compares two medications for gas and bloating.
Checks if a newer version of the medicine works the same way.
Involves healthy adult volunteers (men and women).
Looks at how the body handles the medicine after eating.
You will take both medications during the study.
Helps ensure medicines are equally effective and safe.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. We welcome both men and women to participate.

Since this study is looking at how medicines are handled by a healthy body, you cannot have any ongoing medical conditions that might affect how the medicine works or how your body reacts to it. We'll check your general health carefully to make sure it's safe for you to take part.

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 with no ongoing medical conditions?
Are you able to follow specific study instructions?
Are you comfortable having regular blood samples taken?
Are you willing to take the study medication after a meal?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given both study medications at different times. This is a "crossover" study, which means you will receive one medicine, then take a break, and then receive the other medicine. You'll switch between the two medications over a few visits.

Throughout the study, you'll have blood samples taken after you've taken the medicine and eaten a meal. This helps us measure how much of the medication is in your body and how it's being processed over time. You will also have regular check-ups to make sure you are feeling well. The total duration of your involvement will be explained in full, including the number of visits and any follow-up appointments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation helps us learn more about these medications, which could help future patients. There might be side effects from the study medicines, or discomfort from blood draws. You will be closely monitored for your safety. Remember, you can leave 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
Czechia

Common questions

What does 'healthy subjects' mean?

It means you don't have any major medical conditions that would affect how the medicine works or how your body handles it.

Will I know which medicine I am taking?

Yes, in this type of study, you will know which medicine you are taking at each stage. It's called 'open label'.

What is 'fed conditions'?

This means you will take the study medicine after you have eaten a meal, as directed by the study team.

What is 'bioequivalence'?

It means we're checking if two versions of a medicine are absorbed by the body in a similar way and at a similar rate, so they should work just as effectively.

Is this medicine for a specific illness?

While the medicines are typically for bloating and gas, this study is to understand how they work in healthy people, not to treat a specific illness you might have.