Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, Portugal
Not recruiting
Bioequivalence Study of Ulipristal Acetate 30 mg Tablet in Healthy Subjects Under Fasting Conditions
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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).
The research process
The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Provide a free written informed consent before any study procedures are done.
- Agree to follow all study procedures and any restrictions.
- Be a female who either cannot become pregnant, or if she could become pregnant, agree to use an accepted birth‑control method from at least 4 weeks before the first study period until after the next menstrual period following the last dose.
- Be between 18 and 50 years old at the time of signing the consent.
- Have a body mass index (BMI) between 18.0 and 30.0 kg/m² (a measure of weight relative to height).
- Have no clinically relevant diseases noted in medical history.
- Have no clinically relevant problems found during a physical examination.
- Have no clinically relevant abnormalities on a 12‑lead ECG (a heart test that records the heart’s electrical activity).
- Have no clinically relevant abnormalities on clinical laboratory tests (blood and urine tests).
- Show negative test results for anti‑HIV‑1 and anti‑HIV‑2 antibodies, Hepatitis B surface antigen, and anti‑Hepatitis C virus antibodies (tests that confirm you do not have HIV, hepatitis B, or hepatitis C).
- Be a non‑smoker or an ex‑smoker who has not used tobacco or nicotine products for at least 3 months before screening.
Who cannot join the trial?
26 criteria
- Known hypersensitivity (allergy) to the study drug or any of its inactive ingredients.
- Positive test for illegal drugs or alcohol.
- Received a long‑acting injection or implant of any medication (except birth‑control) within the past 6 months.
- Drank more than 7 units of alcohol each week on average during the past 6 months.
- Consumed more than about 500 mg of caffeine‑containing drinks or foods (e.g., coffee, tea, cola, chocolate) each day.
- Participated in any other clinical trial in the last 2 months.
- Participated in more than two clinical trials in the past 12 months.
- Donated blood or lost a large amount of blood (about 450 mL) or had plasma exchange in the past 2 months.
- Have difficulty fasting or have a dietary restriction (e.g., lactose intolerance, vegan, low‑fat, low‑sodium) that would interfere with the study meals.
- Have veins that cannot be used for an IV line in either arm.
- Have trouble swallowing capsules or tablets.
- Known severe allergy to any other medication.
- Positive pregnancy test in blood.
- Currently breastfeeding.
- Any other condition that the doctor thinks makes participation unsafe.
- Any recent illness, condition, or treatment that could put you at risk or affect how the study drug works in your body.
- Used prescription or over‑the‑counter medicines, vitamins, supplements, or herbal products in the past 2 weeks, unless the doctor says they will not interfere.
- Ate pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit (fresh, canned, or frozen) in the past week.
- Used medicines that strongly affect the liver enzyme CYP3A4 (examples: ketoconazole, itraconazole, erythromycin, clarithromycin) or medicines that increase its activity (examples: barbiturates, phenytoin, carbamazepine, St. John’s wort, rifampicin) or used esomeprazole in the past 4 weeks.
- Known rare inherited problems that affect sugar digestion such as galactose intolerance, lactase deficiency, or glucose‑galactose malabsorption.
- Any gastrointestinal, kidney, or liver disease or surgery (e.g., ulcer, inflammatory bowel disease, pancreatitis, gallbladder removal, stomach removal) that could change how the drug is absorbed or cleared.
- Unusual genital bleeding.
- History of liver problems.
- History of severe asthma.
- Blood test showing liver enzymes ALT or AST higher than normal.
- Kidney function test (creatinine clearance) below 90 mL/min.
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Investigated drugs
Ulipristal acetate (reference product)
is the already approved tablet that contains the active ingredient ulipristal acetate. In this study it is used as the standard medicine to compare the new tablet against. The tablet works by selectively blocking the hormone progesterone, which helps treat conditions like uterine fibroids. Participants in the trial took this tablet on an empty stomach so the researchers could see how the drug is absorbed and processed in the body.
Ulipristal acetate (test product)
is the new tablet formulation being evaluated in the trial. It contains the same active ingredient, ulipristal acetate, and is made to look and be taken the same way as the reference tablet. The purpose of giving this tablet to participants is to determine whether it behaves in the same way as the approved product—meaning it should be absorbed, reach the bloodstream, and work similarly. This helps confirm that the new tablet can be used as a safe and effective alternative.
What is already known about the treatment
ULIPRISTAL ACETATE
This medication is taken by mouth as a 30 mg tablet and is used mainly for emergency contraception and for treating uterine fibroids. It is an approved drug that has been studied extensively in medical literature and is widely available in many countries. It works by binding to progesterone receptors and blocking the hormone’s action, which prevents pregnancy or reduces fibroid growth. It belongs to the class of selective progesterone receptor modulators.
Ulipristal 30 mg tablet
The test product is an oral tablet containing 30 mg of ulipristal acetate and is intended for the same uses as the reference drug, such as emergency contraception and fibroid management. It is a newly formulated tablet that is being compared to the approved product in a bioequivalence study. Like the reference, it blocks progesterone receptors to stop pregnancy or shrink fibroids. It is also classified as a selective progesterone receptor modulator.
Investigated diseases
No medical condition - This study does not involve a specific disease; it assesses the drug in participants who do not have a diagnosed medical condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504258-36-00Protocol codeBLCL-ULI-FDA-01Estimated enrolment60 patientsSponsorLaboratorios Leon Farma S.A.
sourced from the EU Clinical Trials Register and site verification
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