Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Single Dose, Fast State, Bioequivalence Study of CEFIXIMA ATB 400 mg Hard Capsules (Antibiotice S.A.) vs. CEFIXORAL® 400 mg Film Coated Tablets (A. Menarini Industrie Farmaceutiche Riunite s.r.l.)

This research is a 'bioequivalence study,' which means it's comparing two different versions of the same medicine. Both medicines contain 400mg of Cefixime, an antibiotic. One is a capsule made by Antibiotice S.A., and the other is a tablet called CEFIXORAL® made by A. Menarini. The main goal is to see if your body absorbs and processes both medicines in a very similar way when taken on an empty stomach. This is important to ensure that if a doctor prescribes one, it will effectively do the same job as the other. Researchers will also be carefully monitoring for any side effects or changes in your health during the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Antibiotice S.A.

Enrolment target

Start

17 May 2023

healthy subjects

What is this study about?

Imagine you need a specific type of paint for your house. If two different brands create very similar paint, you'd want to know that they both cover the walls just as well. This study is similar, but for medicine. It's comparing two versions of a drug called Cefixime, which is an antibiotic used to treat certain infections.

One version is a capsule and the other is a tablet. The study wants to check if your body handles both of these medicines in the same way. This means looking at how quickly the medicine gets into your bloodstream, how much of it gets there, and how long it stays before your body starts to clear it out. This type of research, called a 'bioequivalence study,' is a standard and important step before a new medicine or a different version of an existing medicine can be widely used. It helps ensure that patients always receive a medicine that works effectively and predictably, regardless of which version they are given.

They are also very keen to make sure the medicines are safe. Researchers will be observing the healthy volunteers closely for any side effects or unexpected changes in their health. This includes monitoring things like vital signs (like blood pressure and heart rate) and routine blood tests, to make sure everything stays within healthy limits.

Key takeaways

This study compares two versions of the same antibiotic, Cefixime.
It aims to see if both versions are absorbed and used by the body in the same way.
Only healthy adults aged 18 and over can participate.
Your safety will be closely monitored with blood tests and vital sign checks.
Participating helps ensure new medicines are safe and work effectively.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be 18 years old or older. Both men and women are welcome to participate.

Since they are testing how your body handles the medicine, it's very important that you are generally well and don't have any major ongoing health problems. They will check your 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 in good health?
Are you able to follow study instructions carefully?
Are you available for clinic visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be one of the healthy volunteers. You'll be given a single dose of one of the Cefixime medicines on an empty stomach. After taking the medicine, a team of doctors and nurses will closely monitor you. This will involve regular blood tests to see how much of the medicine is in your bloodstream over a set period. They'll also check your vital signs (like blood pressure) and ask about how you're feeling to spot any side effects.

You will likely stay at a clinic for a short period after taking the medicine for these measurements. You'll then have a break before repeating the process with the other version of the medicine. The total duration of your involvement, including all visits and follow-ups, would be explained in full detail by the study team.

Potential risks and benefits

The main benefit of taking part in this type of study is helping advance medical knowledge and ensuring medicines are safe and effective for everyone. You might also receive some compensation for your time and travel. While these medicines are generally well-understood, there's always a chance of side effects, just like with any medicine. These could range from mild discomfort to more serious, but rare, reactions. The study team will explain all known risks before you decide to participate, and your safety will be carefully monitored throughout. 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.

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Unverified
Romania

Common questions

What is Cefixime?

Cefixime is an antibiotic medicine used to treat various bacterial infections.

Why do they need healthy people for this study?

Using healthy people helps researchers see how the medicine works in a typical body without other health conditions confusing the results.

Will I get both medicines?

Yes, you will likely receive one type of medicine, then after a break, the other, so researchers can compare them in the same person.

What are 'vital signs'?

Vital signs are basic measurements of your body's function, like your heart rate, blood pressure, temperature, and breathing rate.

Will taking part in this study cost me anything?

The study should cover costs related to your participation, and you may be compensated for your time, but always confirm this with the research team.