Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Single Dose, Fast 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 a new version of a common antibiotic called nitrofurantoin, made by IASIS PHARMA. We're comparing it to an existing version called Furabid® (made by Amdipharm Limited). Both are used to treat bladder infections and are designed to release the medicine slowly in your body. The main goal is to see if the new version works in the same way as the established one, meaning it's absorbed and processed by the body in the same manner. This is an important step when developing new medicines to make sure they are similar enough to older, trusted ones. Healthy adults are taking part in this study to help us understand how these medications behave in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

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

Enrolment target

Start

24 Feb 2025

healthy subjects

What is this study about?

This study, called a 'bioequivalence' study, is a common and important step in bringing new medicines to people. When a drug company makes a new version of an existing medicine, they need to show that it works just as well and is just as safe as the original. This is where bioequivalence studies come in.

In simple terms, we're testing if the new nitrofurantoin medicine (from IASIS PHARMA) travels into the bloodstream and stays there for the same amount of time as the well-known Furabid® medicine. Both are 'prolonged-release' capsules, meaning the medicine is released slowly over time, which often helps reduce how many times you need to take it in a day.

By carefully comparing how both medicines behave in healthy people, researchers can be confident that the new version will have the same effects as the established one. This helps ensure that when you get a prescription for nitrofurantoin, you can trust that it will do its job, no matter which company made it.

Key takeaways

This study compares a new nitrofurantoin medicine with an existing one.
It helps ensure new medicines work the same as trusted ones.
Healthy adult volunteers are needed.
You will take both medicines (at different times) and give blood samples.
Participation helps advance medical knowledge.
You can withdraw at any time.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you simply need to be 18 years old or older, and generally in good health.

Because this study aims to see how the medicine works in a typical person, volunteers should not have any serious ongoing health conditions that might affect how their body handles medication. Both men and women are welcome 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?
Are you generally healthy, without any serious ongoing medical conditions?
Are you comfortable visiting a clinic multiple times?
Are you willing to provide blood samples occasionally?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the study clinic multiple times. During these visits, you'll be given either the IASIS PHARMA nitrofurantoin or the Furabid® medicine, but you won't know which one at the time. After a break, you'll then switch to the other medicine. This helps us compare them fairly. We'll take blood samples regularly after you take each medicine to check how much of it is in your system. This helps us understand how the medicine is absorbed and cleared from your body. The total time you'll be involved in the study will be discussed in detail by the study team, including how many visits there will be and how long each visit will last.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science and helping bring new, important medicines to patients. You'll receive compensation for your time and travel. As with any medicine, there's always a small chance of side effects, which the study team will explain fully. They will closely monitor your health throughout the study. 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 nitrofurantoin used for?

Nitrofurantoin is an antibiotic commonly used to treat bladder infections, also known as urinary tract infections (UTIs).

What does 'prolonged-release' mean?

Prolonged-release means the medicine is designed to release slowly into your body over an extended period. This often means you don't need to take it as often.

What is a 'bioequivalence study'?

It's a study that compares two versions of the same medicine to see if they both act the same way in the body. This is important to ensure new medicines work just like older, trusted ones.

Will I get the actual medicine for a bladder infection?

No, this study is about comparing how the medicine acts in healthy people, not treating an illness. You will receive either the new or existing version of the medication to help researchers understand how it works in your body.

Do I have to take part?

No, taking part in any research study is always completely voluntary. You can decide not to, or change your mind at any time, without it affecting your medical care.