Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Ulipristal 30 mg Tablets in Healthy Subjects Under Fed Conditions

This research is looking at a medication called ulipristal 30 mg. It's a type of study called a 'bioequivalence' study. This simply means the researchers want to make sure that a new version of the tablet works in exactly the same way as an existing one when taken by healthy women. They will check how much of the medicine gets into the body and how quickly, especially when taken with food. This kind of study is a very early step in developing new medicines to ensure they are consistent and reliable. Participants will be healthy women over 18, and it doesn't involve treating any medical condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

29 May 2023

No medical condition

What is this study about?

This particular study is a very early step in understanding how a medicine works in the human body. The medicine being looked at is ulipristal 30 mg. You might have heard of ulipristal as an emergency contraceptive, but it can also be used for other gynaecological conditions.

The main goal of this study is to see if a slightly different version or 'generic' of the ulipristal 30 mg tablet acts the same way as the original one when taken orally. This is called a 'bioequivalence' study. Imagine you have two different brands of a painkiller; this study checks if both brands deliver the same amount of medicine into your body at the same speed. This is really important to make sure that all versions of a medicine are reliable and work as expected. They are specifically testing this when the medicine is taken after eating food.

Because this is an early-stage study, it's about understanding the medication itself, rather than treating a specific illness. Participants in this study will be healthy women, meaning they are not being recruited to treat any health conditions. It's a key part of the process required before a new drug or a new version of an existing drug can be made available to patients.

Key takeaways

It's an early-stage study checking a new version of ulipristal 30 mg tablets.
The study confirms if the new tablet works the same way as an existing one.
Participants must be healthy women, aged 18 or older.
It's not about treating a disease, but understanding how the medicine behaves in the body.
Participation involves taking the medicine with food and providing blood samples.

Who may be eligible?

To be part of this study, you need to be a healthy woman aged 18 or older. There isn't an upper age limit mentioned, so if you're a healthy woman, you might be able to take part.

Because it's a study looking at how a medicine works in healthy individuals, you wouldn't be able to join if you have any ongoing medical conditions that might affect how your body handles medication. The researchers will probably do health checks to make sure you are in good general health.

They haven't given a detailed list here, but in studies like this, factors like pregnancy, breastfeeding, certain medications, or specific health issues (like kidney or liver problems) would usually mean you can't join. The study team will go through all the detailed requirements with you.

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 a woman?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you not currently pregnant or breastfeeding?
Are you able to commit to clinic visits and follow-up activities?

Answer every question to see your result.

What does participation involve?

The information provided is very brief, so we can only give a general idea of what participating in a study like this typically involves.

During your participation, you would likely have a screening visit where doctors check your overall health through examinations, blood tests, and perhaps other checks. If you qualify, you would then receive the study medication (ulipristal 30 mg) during one or more visits to the clinic, usually taken with a meal. Researchers would then take blood samples at regular times to measure how the medicine moves through your body. This often involves staying at the clinic for a day or even a few days per dose, followed by outpatient visits.

There might be different periods where you take one version of the tablet, and then after a washout period (where you don't take any medicine), you would take the other version. This helps compare them accurately. You would have follow-up visits or calls after you finish taking the medication to ensure you are well. The total duration of your involvement could range from a few weeks to a couple of months, including all assessments and follow-ups. All specific details would be explained in full by the study team.

Potential risks and benefits

Participating in a study like this helps advance medical knowledge, ensuring that new versions of medications are safe and work effectively for future patients. You might also receive free health checks during the screening process. Potential risks could include side effects from the study medication, which the study team would explain in detail. There's also the discomfort of blood draws, and the time commitment for visits. Remember, you can decide 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
Portugal

Common questions

What is ulipristal 30 mg used for?

Ulipristal can be used for emergency contraception or, in different doses, for treating certain gynaecological conditions like uterine fibroids. This study tests how a new version of the 30mg tablet works.

Why is this study being done in healthy people?

Early studies like this are done in healthy people to understand how a medicine is absorbed, processed, and removed from the body without interference from existing health conditions or other medications.

What does 'bioequivalence' mean?

It means the study is comparing two versions of the same medicine to confirm that they both get into the body in the same amount and at the same speed, ensuring they work identically.

Will I receive treatment for a medical condition in this study?

No, this study is not designed to treat any medical condition. Participants must be healthy, and the purpose is to study the medication itself, not its effects on an illness.

Will I know if I'm getting the 'new' or 'old' version of the drug?

In many bioequivalence studies, participants might receive both versions at different times, or it might be 'blinded' meaning neither you nor the researchers know which one you are getting at a specific time. All of this will be fully explained to you.