Bioequivalence of Ulipristal 30 mg Tablets in Healthy Subjects Under Fasting Conditions

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Leon Farma S.A.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Female

Therapeutic area

Not possible to specify

Trial duration

1 Sep 2023 → 25 Oct 2023

Decision date (initial)

2023-05-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Laboratorios León Farma, S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence

To demonstrate bioequivalence between Test and Reference products under fasting conditions.

Secondary objectives 1

1. To assess the safety and tolerability of Test product under fasting conditions.

Conditions and MedDRA coding

No medical condition

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Free written informed consent prior to any procedure required by the study.
2. Female subject between 18 and 50 years, inclusive, at the time of signing the informed consent.
3. Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
4. No clinically relevant diseases captured in medical history.
5. No clinically relevant abnormalities on physical examination.
6. No clinically relevant abnormalities on 12-lead ECG.
7. No clinically relevant abnormalities on clinical laboratory tests.
8. 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).
9. Non-smoker or ex-smoker (i.e. someone who abstained from using tobacco- or nicotinecontaining products for at least 3 months prior to Screening).
10. Willingness to accept and comply with all study procedures and restrictions.
11. 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 29

1. Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
2. Known severe hypersensitivity reaction to any other drug.
3. Known rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
4. 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.
5. Abnormal genital bleeding.
6. History of hepatic impairment.
7. History of severe asthma.
8. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
9. 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.
10. Positive result in drugs-of-abuse or ethanol tests.
11. Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
12. Average weekly alcohol consumption of >7 units within the previous 6 months.
13. Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
14. Participation in any clinical trial within the previous 2 months.
15. Participation in more than 2 clinical trials within the previous 12 months.
16. Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
17. 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.
18. Veins unsuitable for intravenous puncture on either arm.
19. Difficulty in swallowing capsules or tablets.
20. Positive pregnancy test in serum.
21. Is breast-feeding.
22. Any other condition that the Investigator considers to render the subject unsuitable for the study.
23. 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.
24. 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.
25. Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
26. 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.
27. Positive result in drugs-of-abuse or ethanol tests.
28. Positive pregnancy test in urine.
29. Any other condition that the investigator considers to render the subject unsuitable for the study period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cmax and AUC0-72 of ulipristal acetate will be the primary pharmacokinetic parameters for the bioequivalence assessment.

Secondary endpoints 1

1. Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Leon Farma S.A.

Sponsor organisation

Laboratorios Leon Farma S.A.

Address

Calle La Vallina S/n

City

Villaquilambre

Postcode

24193

Country

Spain

Scientific contact point

Organisation

Laboratorios Leon Farma S.A.

Contact name

Amparo Amilburu

Public contact point

Organisation

Laboratorios Leon Farma S.A.

Contact name

Amparo Amilburu

Third parties 4

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications