A study to compare how perampanel is absorbed in healthy adult men and women.

1 1 1 1

What is this study about?

This study aims to compare how the body absorbs two different versions of the same medication. The medication being studied is perampanel, which is used to treat epilepsy, a condition that causes recurring seizures. The two versions being compared are the test product, Perampanel, and the reference product, Fycompa.

The study is a bioequivalence study, which means researchers are checking if the test version of the medicine works in the same way and is absorbed by the body at the same rate as the original version. This process involves measuring how much of the drug enters the bloodstream and how quickly it reaches its highest concentration. Participants will take a single dose of the medication while in a fasting state, meaning they will not eat for a certain period before and after taking the tablet.

The study uses a crossover design, where participants receive both types of the medication at different times during the study period. This allows for a direct comparison between the two products within the same individuals. The research is conducted under open-label conditions, meaning both the participants and the researchers know which version of the medication is being administered during each phase.

Who Can Join the Study?

You must be a healthy male or a female who is not pregnant and not currently breastfeeding.
You must be between 18 and 55 years old on the day you agree to join the study.
You must be a non-smoker or a former smoker who has not smoked for at least 6 months before taking the first dose of the study medicine.
Your Body Mass Index (BMI), which is a measure of your weight in relation to your height, must be between 18.5 and 30.0 kg/m².
You must be available for the entire duration of the study and provide written informed consent, which is your formal agreement to participate after understanding all details.
You must be in good health, as confirmed by a review of your medical history, a physical exam, and checks of your vital signs (such as heart rate, body temperature, and blood pressure, which is the force of blood against your artery walls).
You must undergo a 12-lead ECG, which is a test that records the electrical activity of your heart.
Your laboratory screening results, such as blood or urine tests, must fall within the normal range.
Female participants who can become pregnant must use highly effective contraception (methods to prevent pregnancy, such as hormonal birth control or an intrauterine device) and must also use a barrier method, like a condom, because the study medicine can make hormonal methods less effective.
Male participants must use contraception if their partner can become pregnant.
Contraceptive methods must be used during the study and for at least 40 days after the study ends.
You must be able to speak and understand Czech fluently.

Who Cannot Join the Study?

Having any acute or chronic diseases (short-term or long-term illnesses) or medical conditions that could interfere with the study’s goals or affect how the study drug works in your body.
Having received a tattoo, body piercing, or any skin-piercing cosmetic procedure within 90 days before the screening, unless a doctor decides it is not important for the study.
Testing positive for drug abuse in a urine test during screening or when checking in.
Testing positive for alcohol during a breath test during screening or when checking in.
Testing positive for cotinine (a substance found in the body after using nicotine/tobacco) in a urine test during screening.
Female participants who are pregnant (confirmed by blood or urine tests), are breastfeeding, or cannot provide pregnancy test results.
Having a body temperature of 37.0 °C or higher during screening or when checking in.
Having blood pressure readings outside the normal range (90-140 mmHg for the top number, 60-90 mmHg for the bottom number) or a heart rate (beats per minute) outside the range of 50-100 bpm after resting for 5 minutes.
Testing positive for HBsAg (Hepatitis B), HCV (Hepatitis C), or HIV (a virus that affects the immune system) during screening.
Having anaemia, which means having low levels of haemoglobin (a protein in red blood cells that carries oxygen) below 120 g/L for women or 130 g/L for men.
Participating in another medical study within 30 days of starting this study.
A history of significant hypersensitivity (severe allergic reactions) to the study drug, its ingredients, or other medications, such as angioedema (severe swelling under the skin).
A history of liver diseases with high levels of transaminases (liver enzymes like ALT or AST that show if the liver is stressed or damaged).
A history of rare inherited problems with processing sugars, such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
A history of suicidal or homicidal behavior, tendencies toward such behavior, or previous attempts.
Having received a COVID-19 vaccine less than 14 days before screening or planning to get a vaccine during the study.
Being hospitalized due to COVID-19.
Testing positive for SARS-CoV-2 (the virus that causes COVID-19) via a PCR or antigen test.
Having a serious mental illness or being unable to work together with the medical team.
Abuse of drugs, alcohol (more than 40g of pure ethanol per day for men or 20g for women), or solvents, or being unable to stop consuming foods with methylxanthine (such as coffee, tea, chocolate, or energy drinks) for 48 hours before each drug dose.
Having a significant illness or undergoing major surgery within 28 days before the first dose.
Taking any over-the-counter (OTC) medicines (drugs you can buy without a prescription), vitamins, herbal treatments (like Saint John’s Wort), or food supplements within 14 days before the first dose.
Taking any prescription medication within 28 days before the first dose, except for hormonal contraceptives or hormone replacement therapy that has not changed in dose for 90 days.
Using organ-toxic drugs (medicines that can damage organs) or drugs known to change how the liver processes substances within 90 days before the first dose.
Donating or losing at least 500 mL of blood within 90 days, or donating plasma (the liquid part of blood) or platelets (cells that help blood clot) within 14 days before the first dose.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Quinta-Analytica s.r.o.	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	05.06.2023

Trial locations

Investigated drugs:

Perampanel

Perampanel is the medication being tested in this study to see how well the body absorbs it compared to the existing version. It is used to treat certain types of seizures.

Fycompa is the existing medication used as a comparison to the test product. It is also used for the treatment of seizures, and the study aims to ensure the new version works in a similar way.

The provided source data indicates that the study is a bioequivalence trial conducted in healthy subjects and does not list any specific diseases being studied. Therefore, no disease descriptions can be provided.

Trial ID:

2023-503345-59-00

Protocol code:

CFA-1031-1-22

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study to compare how perampanel is absorbed in healthy adult men and women.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?