Bioequivalence Study of Ticagrelor 90 mg Capsules (PG402) vs Tablets in Healthy Volunteers for Prevention of Acute Coronary Syndrome

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What is this study about?

The study involves a medication called ticagrelor, which is used to help prevent dangerous blood clots in people who have experienced an acute coronary syndrome or a myocardial infarction and are at high risk of another clot‑related event. Two versions of the same medicine are being compared: a hard capsule identified as PG402 and a film‑coated tablet marketed as Brilique. Both contain the same active ingredient and are taken by mouth.

The purpose of the trial is to determine whether the two formulations are bioequivalence, meaning they deliver the same amount of medication to the body in the same amount of time. Healthy volunteers will be assigned at random to receive one form of the drug after an overnight fast, then, after a short break, will receive the other form under the same conditions. This allows researchers to compare how quickly and how much of the drug appears in the bloodstream without using any invasive procedures.

1 enrollment and randomization

after joining the study you are assigned by chance to receive either the hard capsule (pg402) or the film‑coated tablet (brilique) first. this process is called randomization and ensures the order of medication is balanced across participants.

2 first dosing under fasting conditions

you will be asked to fast, meaning no food or drink (except water) for a period before taking the medication.

you will swallow one ticagrelor dose of 90 mg taken by mouth. the medication is either the hard capsule or the tablet, depending on the randomization result. this is a single dose and is not repeated during this period.

3 blood sample collection after first dose

following the dose, multiple blood samples will be taken over several hours while you remain fasting. these samples are used to measure the level of ticagrelor in your blood, which helps determine the primary study outcomes (cmax and auc).

4 washout period

after the first set of blood draws, there will be a break long enough for the medicine to leave your body completely. this interval is called the washout period. no study medication is taken during this time.

5 second dosing under fasting conditions

you will again fast before taking the study medication.

you will now receive the alternative form of ticagrelor that you did not take in the first period: if you first took the capsule, you will now take the tablet, and vice versa. the dose is also a single oral dose of 90 mg.

6 blood sample collection after second dose

as after the first dose, several blood samples will be drawn over a few hours while you stay fasting. these samples allow comparison of the two formulations.

7 study completion and final assessment

once all blood samples are collected, the study team will evaluate the data to determine whether the two ticagrelor products are equivalent in how they are absorbed.

you will be informed that the study procedures are finished and any remaining study requirements will be completed.

Who Can Join the Study?

Ethnic origin: You must be of Caucasian background.
Gender: Both men and women are allowed.
Age: You must be at least 18 years old and no older than 55 years on the day of screening.
Body‑mass index (BMI): Your BMI must be between 18.5 and 29.99. BMI is a measure that uses your height and weight to estimate body fat.
Physical examination: A doctor will check you (look, feel, tap, and listen to your body) and you must have no significant health problems found.
Clinical laboratory tests: Blood and urine tests must be normal according to the study’s standards.
Non‑smoker: You must not have smoked or used any tobacco products for at least three months before screening.
Written informed consent: You must be able to read and sign a form that shows you understand the study and agree to take part.
Signed consent form: The consent form must be signed and dated before any screening tests are done.
Willingness to follow the study rules: You must agree to do everything required by the study schedule and procedures.
Contraception for participants who could become pregnant: If you (or your partner) could have children, you must use an acceptable birth‑control method, such as total abstinence, condoms, diaphragms, an intrauterine device, or hormonal pills. Men must start using it at screening and continue for 90 days after the study; women must start at least four weeks before screening and continue for 30 days after the study.

Who Cannot Join the Study?

Having an allergy (a reaction causing symptoms like rash, itching, or swelling) or strong sensitivity to the study drug ticagrelor or any of its inactive ingredients.
Having a serious current or past illness of the heart, lungs, blood, hormone system, nerves, muscles, digestive or urinary systems, severe allergies, genetic conditions, mental health disorders, or an infection in the last two weeks that could affect overall health.
Having a bleeding disorder that you were born with (congenital) or developed later (acquired).
Having ongoing abnormal bleeding (for example, heavy nosebleeds or bleeding that does not stop).
Having a history of bleeding inside the brain (intracranial hemorrhage).
Being prone to bleed, such as after a recent injury, recent surgery, clotting problems, or recent stomach or intestinal bleeding.
Having a history of fainting caused by a very slow heart rate (bradycardic‑related syncope).
Having a current disease of the digestive tract, liver, or kidneys that could change how the study drug is absorbed, spread, or removed from the body.
Needing to take other medicines (except certain fast‑acting pain relievers) within four weeks before the first dose and during the whole study.
Having taken part in another clinical trial where a study drug was given within the past 90 days before screening.
Having had a large blood draw of 300 mL or more within the 30 days before joining the study.
Testing positive on a pregnancy test at screening or before any treatment period (for female volunteers).
Being currently breastfeeding (lactating) (for female volunteers).
Having low blood pressure (hypotension) or high blood pressure (hypertension) that the doctor considers important, at screening or before any treatment period.
Having a narcotic or alcohol addiction, or drinking more than 14 units of alcohol per week (about one bottle of wine, two cans of beer, or a small glass of strong spirits) within the past year.
Testing positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies.
Testing positive on a COVID‑19 antigen test.
Testing positive on a drug screen or an alcohol breath test.
Following a special diet (for example, low‑calorie, vegetarian, or other restricted diets).
Being considered by the investigator to be unsuitable for any reason.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bfyncoelbae Guhsu Shm z orzw	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	04.09.2023

Trial locations

Investigated Drugs:

Ticagrelor

PG402 is a hard capsule that contains the blood‑thinner ticagrelor. In this study it is the new, test product being evaluated to see if it works the same way as an existing medicine. Volunteers take the capsule by mouth while fasting, and researchers measure how the drug is absorbed and processed in the body.

Brilique is a film‑coated tablet that also contains ticagrelor. It is the established, reference product used to prevent blood clots in people at risk of heart problems. In the trial it serves as the comparator, allowing researchers to compare its performance with the test capsule under the same conditions.

Investigated Diseases:

Myocardial infarction

Acute coronary syndrome – Acute coronary syndrome refers to a group of conditions caused by a sudden reduction of blood flow to the heart, often due to a clot forming on a ruptured plaque in a coronary artery. It includes unstable angina and heart attacks that develop rapidly, producing chest discomfort and other symptoms. If the blockage persists, the heart muscle can become damaged, and the condition may progress to more extensive injury.

Myocardial infarction – Myocardial infarction, commonly called a heart attack, occurs when a coronary artery is blocked and blood can no longer reach part of the heart muscle. The lack of oxygen leads to death of heart muscle cells, causing persistent chest pain and related signs. Over time, the dead tissue is replaced by scar tissue, which can reduce the heart’s pumping ability and affect overall heart function.

Trial ID:

2023-504116-14-00

Protocol code:

01TICA2023

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Bioequivalence Study of Ticagrelor 90 mg Capsules (PG402) vs Tablets in Healthy Volunteers for Prevention of Acute Coronary Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?