Bioequivalence Study of Ticagrelor 90 mg Hard Capsules Versus Film-Coated Tablets in Healthy Volunteers for Atherothrombotic Event Prevention

Trial ID: 2023-504116-14-00
Protocol: 01TICA2023
Sponsor: Celon Pharma S.A.

Trial statistics

science

test molecules

location_city

research site

public

country

medical_information

disease

person_search

investigator

handshake

vendors

Diseases & Conditions

Myocardial infarction

Objectives

The primary objective of this study is to evaluate the **bioequivalence** of ticagrelor 90 mg hard capsules (PG402 [Celon Pharma]) compared to ticagrelor 90 mg film-coated tablets (Brilique [AstraZeneca AB]) under fasting conditions in healthy volunteers. This is clinically relevant as ticagrelor is used for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) who are at high risk of developing an atherothrombotic event. Establishing bioequivalence ensures that the new formulation provides the same therapeutic effect and safety profile as the existing product.

Participants

The clinical trial focuses on the **prevention of atherothrombotic events** in adult patients with acute coronary syndromes or a history of myocardial infarction who are at high risk of developing such events. The study population includes both male and female participants, with an age range classified under category code 3, which typically corresponds to adults. The trial involves a vulnerable population, indicating that special considerations are taken into account for the participants' safety and ethical treatment. However, the sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The absence of detailed participant data limits the ability to provide a comprehensive overview of the study population.

Plans and Procedures

The clinical trial is designed as a **randomized**, open-label, single-dose, 2-way crossover bioequivalence study. It aims to compare ticagrelor 90 mg hard capsules (PG402 [Celon Pharma]) with ticagrelor 90 mg film-coated tablets (Brilique [AstraZeneca AB]) under fasting conditions in healthy volunteers. The study is conducted to assess the **bioequivalence** of the two formulations, which is crucial for ensuring therapeutic consistency and safety in the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of **myocardial infarction** (MI) and a high risk of developing an atherothrombotic event.

The trial is expected to commence recruitment on September 4, 2023, and conclude by October 17, 2023. Participants will be involved in the study for a duration that includes an initial screening visit, followed by two treatment periods, and a final end-of-study visit. The screening visit will determine eligibility based on predefined inclusion and exclusion criteria. Each treatment period will involve the administration of one of the ticagrelor formulations, with a washout period in between to prevent carryover effects. The end-of-study visit will assess the overall health and safety of the participants post-treatment.

Participants are expected to remain in the study for the entire duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions, non-compliance with study protocols, or withdrawal of consent. The study is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants. The trial's design and methodology are structured to provide robust data on the bioequivalence of the two ticagrelor formulations, contributing to informed decisions in clinical practice.

Treatment

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Efficacy

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on September 4, 2023, with an estimated end date of October 17, 2023. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure accurate and reliable measurement of efficacy parameters. Data collection and analysis will be performed at designated timepoints throughout the trial duration, adhering to standard clinical trial protocols. The trial's focus is on evaluating the treatment's impact on the specified medical condition, with the aim of determining its therapeutic potential and safety profile.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

Ethnic origin: Caucasian, 2. Gender: female or male, 3. Age: ≥ 18 to ≤ 55 years old, inclusive, on the day of Screening, 4. Body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 29.99 kg/m², 5. Physical examination (such as observation, palpation, percussion and auscultation) without any clinically relevant abnormality, 6. Proper results of the clinical laboratory tests, 7. Non-smoker and non-user of tobacco products for at least 3 months before screening, 8. Subject able to provide written informed consent after receiving information about the trial, 9. Informed Consent Form signed and dated prior to Screening evaluations, 10. Ability and willingness to comply with the requirements of the study protocol, 11. Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception: complete abstinence from sexual intercourses or barrier method of spermicide (condom, diaphragm) or intrauterine device or hormonal contraceptive since at least screening evaluations for male volunteers and since at least 4 weeks before screening for female volunteers. Volunteers are furthermore willing to use it for 90 days (males) or 30 days (females) after examination at the end of the study.

cancel

Exclusion Criteria

Subject with known allergy, hypersensitivity, intolerance or contraindication to ticagrelor, or to any excipients of the formulation, 2. Any known significant current or past acute or chronic disease or condition of the: circulatory, respiratory, hematopoietic, endocrine, nervous, musculoskeletal system, alimentary and urinary tract, allergic disease, genetic or psychiatric disorder or acute infection within 2 weeks before screening that could influence the present general health condition, at the Investigator’s discretion, 3. Congenital or acquired bleeding disorders, 4. Active pathological bleeding, 5. Intracranial haemorrhage in medical history, 6. Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding), 7. Bradycardic-related syncope in medical history, 8. Current disease of the alimentary tract, liver or kidneys that may influence absorption, distribution and/or elimination of the studied drug, as assessed by the Investigator and documented in medical history, 9. Medical condition that requires administration of other drugs or use of any drug within the 4 weeks preceding the first IMP administration and during the entire study. Drugs commonly used with fast metabolism may be administered and is up to Investigator discretion (i.e. pain killers), 10. Participation in other clinical trials, where at least one dose of study drug was administered, within 90 days preceding the screening phase, 11. Blood drawn within 30 days prior to inclusion in this study (more or equal to 300 mL), 12. Positive results from pregnancy test in female volunteers on Screening Day or before each treatment period, 13. Lactation in female volunteers, 14. Hypotension or hypertension in medical history, on Screening Day or before each treatment period, if Principal Investigator is to assess it as clinically relevant, 15. Narcotic and alcohol addiction or abuse (more than 14 alcohol units per week: one unit = 150 mL wine, 360 mL beer, 45 mL 40 % spirits) (UK guidelines) within last 1 year before screening, 16. Positive results of HBsAg, anti-HCV or anti-HIV, 17. Positive result of antigen Covid-19 test, 18. Positive drug screen or alcohol breath tests, 19. Subjects who adhere to a special diet (e.g. low calories, vegetarian, etc.), 20. The subject is considered by the Investigator to be an unsuitable candidate to participate in the study for any reason.