Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Single Dose, Fed state, Crossover Replicate Bioequivalence Study of NITROFURANTOIN 100 mg prolonged-release capsules (Iasis Pharma) vs. FURABID® 100 mg prolonged-release capsules (Amdipharm Limited)

This research study is looking at two types of 100mg nitrofurantoin capsules. Nitrofurantoin is a common medicine prescribed for bladder and urinary tract infections. One version is already available (called FURABID®), and the other is a new version made by Iasis Pharma. The main goal is to see if the new capsule acts in the body in the same way as the already approved one. This is called a 'bioequivalence' study. It helps ensure that the new medicine will be just as safe and work just as well as the original. The study will involve healthy adults and is one of the first steps in testing a new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Antibiotice S.A., Iasis Pharmaceuticals Hellas S.A.

Enrolment target

Start

19 Jul 2023

healthy subjects

What is this study about?

Imagine you have a headache and take a painkiller. You trust that it will work. Medicines, even those that contain the same active ingredient, can sometimes be made by different companies. This study is like a comparison test for two different versions of a medicine called nitrofurantoin. Nitrofurantoin is commonly used to treat bladder infections, also known as urinary tract infections.

The study wants to find out if a new version of nitrofurantoin 100mg capsules, made by Iasis Pharma, works in exactly the same way as a version that is already on the market, called FURABID®. This is really important because it means that patients can expect the same safe and effective treatment no matter which company makes their medicine. It's about ensuring consistency and reliability.

By carefully checking how the body uses and processes both medicines, researchers can be sure that the new option will provide the same benefits. This type of study is a standard part of developing new medications and making sure they meet strict safety and quality standards before they can be prescribed to patients.

Key takeaways

Compares a new nitrofurantoin capsule to an existing one.
Aims to ensure new medicine works just as well and safely.
Involves healthy adult volunteers.
Focuses on how the body uses the medicine.
Typically involves multiple visits and blood samples.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should not have any serious ongoing medical conditions, and you won't be taking other regular medications that could interfere with the study.

To be eligible, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate as long as they meet the other health requirements.

Both men and women are welcome to join this study. The research team will do medical checks to make sure it's safe for you to participate.

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 several clinic visits?
Are you comfortable with having blood samples taken?
Are you not currently taking other regular medications that might interfere with a study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a few visits to a research clinic. You would be given a single dose of one of the study medicines (either the new nitrofurantoin or the existing one) on one occasion, and then a single dose of the other medicine on another occasion. This is called a 'crossover' study, meaning you get both treatments at different times.

Throughout the study, blood samples would be taken regularly after you take the medication. This helps the researchers see how your body absorbs and processes the medicine. You would likely stay at the clinic for several hours on the dosing days. During these visits, your general health would be monitored. The study takes place in the 'fed state,' meaning you would take the medicine after eating a meal. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to take part.

Potential risks and benefits

A potential benefit of taking part is contributing to medical science and helping to ensure new medicines are safe and effective for future patients. You might also receive some financial compensation for your time and travel. Potential risks usually relate to common side effects of nitrofurantoin (like nausea or headache, although this is a single dose) or the procedure itself, such as discomfort from blood draws. You will be fully informed of all known risks before you decide to participate. Remember, you can 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 nitrofurantoin used for?

It's a medicine commonly used to treat bladder infections, also known as urinary tract infections (UTIs).

What does 'bioequivalence' mean?

It means the study is checking if two different versions of a medicine work the same way in your body, just as safely and effectively.

Who can join this study?

It's looking for healthy adults, at least 18 years old, both men and women, who don't have other serious medical conditions.

Will I get the new medicine or the old one?

You will receive both at different times during the study to allow for a fair comparison.

Will I be paid to take part?

Often, studies like this offer some compensation for your time and travel, but you should ask the research team for details.