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A study to compare how the body absorbs perampanel in healthy adult men and women during fasting conditions

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What is this study about?

This study is designed to compare how the body absorbs two different versions of the medication perampanel. This medicine is typically used to treat epilepsy, a condition that affects the brain and can cause seizures. The two versions being compared are the test product, known as Perampanel 2 mg film-coated tablets, and the reference product, known as Fycompa.

The purpose of the study is to evaluate the bioequivalence, which means checking if both medications work in the same way and are absorbed by the body at similar rates. Participants will take a single dose of either the test product or the reference product while in a fasting state, which means they will not have eaten for a certain period before taking the medication. The study uses a crossover design, meaning participants will receive both types of medication at different times during the study period.

Who Can Join the Study?

  • Participants must be healthy males or females who are not currently pregnant or breastfeeding.
  • Participants must be between 18 and 55 years of age on the day they sign the consent form.
  • Participants must be non-smokers or former smokers who have not smoked for at least 6 months before taking the study medication.
  • Participants must have a Body Mass Index (BMI), which is a measure of body fat based on height and weight, between 18.5 and 30.0.
  • Participants must be available for the entire duration of the study and provide written informed consent, which is a signed document agreeing to take part.
  • Participants must be in good health, which is confirmed by reviewing medical history, a physical exam, vital signs (such as heart rate, body temperature, and blood pressure), and a 12-lead ECG, which is a test that records the electrical activity of the heart.
  • All laboratory screening results, such as blood or urine tests, must fall within the normal range.
  • Female participants who could become pregnant must agree to use highly effective contraception, which are methods like hormonal pills, implants, or devices used to prevent pregnancy, and must continue using them for at least 30 days after the study ends.
  • Male participants must also use contraception or barrier methods, such as condoms, if their partner could become pregnant.
  • Participants must be able to speak and understand Czech fluently.

Who Cannot Join the Study?

  • You have any acute or chronic diseases, which are short-term or long-lasting health conditions, that could affect the study results or your safety while taking the study drug.
  • You have received a tattoo, body piercing, or any cosmetic skin treatment involving piercing within 90 days before the screening, unless the study doctor decides it is not important for the study.
  • Your urine drug test or alcohol breath test shows positive results for drug or alcohol use during screening or check-in.
  • Your urine cotinine test is positive, which means there are traces of nicotine (the substance found in tobacco) in your system.
  • You are a female who is pregnant, breastfeeding, or unable to provide a pregnancy test result.
  • Your body temperature is 37.0 °C or higher during screening or check-in.
  • Your blood pressure is not between 90-140 mmHg for the top number (systolic) and 60-90 mmHg for the bottom number (diastolic), or your heart rate is not between 50-100 beats per minute.
  • You test positive for HBsAg (Hepatitis B), HCV (Hepatitis C), or HIV (a virus that affects the immune system).
  • You have anaemia, which means your haemoglobin (the protein in red blood cells that carries oxygen) is below 120 g/L for women or 130 g/L for men.
  • You have participated in another clinical study within the last 30 days.
  • You have a history of significant hypersensitivity, which is a severe allergic reaction, to the study drug, its ingredients, or any other medications, such as angioedema (swelling deep under the skin).
  • You have a history of liver diseases or have high levels of serum transaminases, which are enzymes (ALT or AST) that indicate liver irritation or damage.
  • You have rare inherited conditions involving trouble processing certain sugars, such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
  • You have a history of suicidal or homicidal behavior, tendencies toward such actions, or previous attempts.
  • You received a COVID-19 vaccine less than 14 days before screening or plan to be vaccinated during the study.
  • You have been hospitalized due to COVID-19.
  • You test positive for the SARS-CoV-2 virus via a PCR or antigen test.
  • You have a serious mental disease or are unable to cooperate with the medical team.
  • You misuse drugs or alcohol (more than 40 grams of pure ethanol per day for men or 20 grams for women), use solvents, or cannot stop consuming foods with methylxanthine (like coffee, tea, chocolate, or energy drinks) for 48 hours before taking the drug.
  • You have had a clinically significant illness or major surgery within 28 days before the first dose.
  • You have taken any over-the-counter drugs (medicines bought without a prescription), vitamins, herbal treatments, or food supplements within 14 days before the first dose.
  • You have taken any prescription medications within 28 days before the first dose, unless it is hormonal contraceptives or hormone replacement therapy that has remained at the same dose for 90 days.
  • You have used organ-toxic drugs or medications known to change how the liver processes medicine within 90 days before the first dose.
  • You have donated blood (500 mL or more), plasma, or platelets within a specific recent timeframe before the first dose.

Where you can join this trial?

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Verified Sites

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Other Sites

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

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
03.07.2023

Trial locations

Investigated drugs:

Perampanel is a medication being tested in this study to see how well it is absorbed and used by the body.

Fycompa is a medication used as a comparison to the test product to check if it performs in a similar way within the body.

The provided source data indicates that the study is a bioequivalence trial conducted in healthy human subjects rather than a study of a specific disease. Consequently, no disease is being studied.

Trial ID:
2023-504132-18-00
Protocol code:
CFA-1031-2-23
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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