Bioequivalence Study of Ulipristal Acetate 30 mg Tablets in Healthy Volunteers Under Fasting Conditions
- Trial ID
- 2023-504258-36-00
- Protocol
- BLCL-ULI-FDA-01
- Sponsor
- Laboratorios Leon Farma S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of Ulipristal 30 mg tablets in healthy subjects under fasting conditions. This is clinically relevant as it ensures that the generic formulation of Ulipristal is therapeutically equivalent to the reference product, maintaining efficacy and safety for patients. No secondary objectives are specified for this study.
Participants
The clinical trial involves a study population consisting exclusively of **female** participants, with an age range categorized as **3**, which typically corresponds to a specific age group as defined in clinical research. The trial does not focus on any specific medical condition, as indicated by the absence of a targeted disease or disorder. The sponsor has not provided information regarding the total number of participants involved in the study. The selection process for the trial population is not detailed, and there is no information on lifestyle considerations such as diet, physical activity, or habits. The trial includes a vulnerable population, although specific details about the nature of this vulnerability are not disclosed. The sponsor has not provided key inclusion or exclusion criteria for this study.
Plans and Procedures
The clinical trial is designed to evaluate the **bioequivalence** of Ulipristal 30 mg tablets in healthy subjects under fasting conditions. This study is a Phase 2 trial, categorized as a bioequivalence study, and does not involve any specific medical condition. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is June 9, 2023, with an anticipated end date of August 1, 2023, indicating a total trial duration of approximately two months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve obtaining informed consent, reviewing medical history, and conducting necessary baseline assessments. Following successful screening, participants will be randomized to receive either the test or reference product under fasting conditions. Subsequent follow-up visits will be scheduled to monitor the participants' health status, collect pharmacokinetic data, and ensure adherence to the study protocol. The end-of-study visit will involve final assessments to evaluate the primary and secondary endpoints of the trial.
The expected length of participant involvement is approximately two months, aligning with the overall trial duration. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.
Treatment
The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.
Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on June 9, 2023, with an estimated end date of August 1, 2023. The efficacy of the investigational treatment will be evaluated through specific parameters, although these parameters are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific endpoints, are not specified in the available information. The trial will adhere to rigorous standards typical of Phase 2 studies to ensure the reliability and validity of the efficacy assessments.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Free written informed consent prior to any procedure required by the study.
- 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).
- 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.
Exclusion Criteria
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- 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.
- 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.
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Portugal | Not Recruiting | 09 Jun 2023 | 60 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
ULIPRISTAL ACETATE | Comparator | — | ORAL | 30 | 1 | SUB30470 |
Ulipristal 30 mg tablet | Test | TABLET | ORAL | 30 | 1 | PRD10267993 |