Bioequivalence of Ulipristal Acetate 30 mg Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.
This study is a bioequivalence trial, which means it compares two versions of the same medicine to make sure they are absorbed into the body in the same way. The medicine being tested is ulipristal acetate, a 30mg tablet. We want to see if a new version acts identically to an existing one. Healthy women aged 18 and over will take part. Participants will receive both versions of the tablet at different times, so we can compare how much of the medicine gets into their blood and how quickly. This research helps ensure that new generic medicines are just as safe and effective as the original brand-name drugs, providing more options for patients.
At a glance
What is this study about?
This research is a 'bioequivalence' study. Imagine you have a favourite brand of crisps, and another company brings out their own version. This study is a bit like testing to see if the new crisps taste exactly the same and have the same crunch as your favourite ones. In this case, we're comparing two versions of a medicine called ulipristal acetate (30mg tablets). We want to make sure that a new version of the tablet is absorbed into the body in exactly the same way as an existing one.
Why does this matter? When a company makes a new version of a medicine that is already available, it's really important to prove it works just as well. This type of study ensures that if doctors prescribe the new version, patients will get the same amount of medicine into their system, meaning it will be just as effective and safe. It's a vital step before a new medicine can be widely used.
This study will help us understand how the ulipristal acetate medicine behaves in healthy people. We'll be looking carefully at how much of the medicine enters the bloodstream and how quickly it gets there. We'll also be keeping a very close eye on the health and safety of everyone taking part. This kind of research allows more access to important medicines by ensuring new versions are reliable and trustworthy.
Key takeaways
- This study compares two versions of a 30mg medicine called ulipristal acetate.
- It's for healthy women aged 18 and over, and aims to ensure new medicines work the same as existing ones.
- Participation involves taking both medicines and having blood tests to see how they are absorbed.
- Your health will be carefully monitored throughout the study.
- It helps bring new, reliable generic medicines to patients.
Who may be eligible?
This study is looking for healthy women to take part. To be eligible, you need to be at least 18 years old. There's no upper age limit, as long as you meet the other health requirements.
Because this study is about how a medicine is handled by the body, rather than treating a specific illness, you generally need to be in good health. This means you shouldn't have any major ongoing medical conditions or be taking medicines that might affect the study results.
Further checks will be carried out to make sure it's safe for you to participate. These checks might include blood tests, a heart tracing (ECG), and an assessment of your overall health.
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?
- Are you generally in good health with no major ongoing medical conditions?
- Are you not currently taking medicines that might interfere with the study?
What does participation involve?
If you decide to take part, you'll visit the study clinic several times. You will be given two different versions of the ulipristal acetate 30mg tablet on separate occasions (meaning you'll try each one at different times). You'll need to be fasting (not eating) before taking the medicine.
After you take each tablet, blood samples will be taken regularly over a period of up to 72 hours (3 days) to measure how much of the medicine is in your body. We'll also monitor your vital signs (like blood pressure and heart rate), take ECGs (heart tracings), and do blood and urine tests to check your overall health and safety throughout the study. The total duration of your involvement, including all visits and follow-ups, will be clearly explained to you.
Potential risks and benefits
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Common questions
What is ulipristal acetate?
Ulipristal acetate is a medicine used in 30mg tablets. This study is not about its use, but how it's absorbed by the body.
Is this study testing a new medicine for a specific disease?
No, this study isn't about treating an illness. It's comparing two versions of an existing medicine to make sure they work the same way.
Will I get to know my results?
Generally, individual results from bioequivalence studies are not shared with participants, as the focus is on comparing the medicines, not your personal health.
Will I have to stay overnight for the study?
Depending on the study setup, you might need to stay at the clinic for certain periods, especially during the 72-hour blood sampling phase. This will be fully explained.
Will I be paid for taking part?
Many clinical studies offer some reimbursement for your time, travel, and inconvenience. This will be discussed before you agree to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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