Bioequivalence Study of Ulipristal Acetate 30 mg Tablet in Healthy Subjects Under Fasting Conditions

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What is this study about?

The study involves healthy volunteers who will receive a single oral dose of a 30 mg tablet containing ulipristal acetate. Both a test tablet and a reference tablet with the same active ingredient are used, allowing comparison of how the body absorbs each version of the medicine.

The purpose of the trial is to show that the test tablet is bioequivalent to the reference tablet, meaning it provides the same amount of drug in the bloodstream. Participants will fast, meaning they will not eat for several hours, before taking one tablet; after a short break to let the first dose clear from the body, they will take the other tablet, with simple check‑ins at each visit.

Safety will be monitored by recording any unwanted effects, checking vital signs such as blood pressure and heart rate, performing laboratory tests, and conducting an ECG (a quick, painless test that records the heart’s electrical activity).

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not recruiting
09.06.2023

Trial locations

Investigated drugs:

Trial ID:
2023-504258-36-00
Protocol code:
BLCL-ULI-FDA-01
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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