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Bioequivalence of Ulipristal 30 mg Tablets in Healthy Subjects Under Fasting Conditions
EU CTIS ID: 2023-504258-36-00
What this study is testing
To demonstrate bioequivalence between Test and Reference products under fasting conditions.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until at least the next menstrual period after last dose.
- Female subject between 18 and 50 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
You likely can't join if
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >7 units within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until at least the next menstrual period after last dose.
- Female subject between 18 and 50 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV- 1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Non-smoker or ex-smoker (i.e. someone who abstained from using tobacco- or nicotinecontaining products for at least 3 months prior to Screening).
What rules you out
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >7 units within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- Known severe hypersensitivity reaction to any other drug.
- Positive pregnancy test in serum.
- Is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or non-prescription medicinal products, such as vitamins, food supplements or herbal supplements, within the previous 2 weeks, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
- Use of CYP3A4-inhibitor drugs (antiproteases, ketoconazole, itraconazole, erythromycin and clarithromycin), CYP3A4-inducer drugs (barbiturates, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum [St. John’s wort], rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long-term use of ritonavir) or esomeprazole within the previous 4 weeks.
- Positive result in drugs-of-abuse or ethanol tests.
- Positive pregnancy test in urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
- Known rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Abnormal genital bleeding.
- History of hepatic impairment.
- History of severe asthma.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.