A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing ticagrelor 90 mg hard capsules (PG402 [Celon Pharma]) vs ticagrelor 90 mg film-coated tablets (Brilique [AstraZeneca AB]) under fasting conditions in healthy volunteers
EU CTIS ID: 2023-504116-14-00
What this study is testing
To investigate bioequivalence of test product to reference product
- 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
- 1. 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.
You likely can't join if
- 1. 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.
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 all sexes, 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.