Trials Sponsors Conditions Drugs Pricing

Conditions

N.A. (submitted trial is a bioequivalence study in healthy human subjects)

Outcome Measures

Primary Outcomes (1)

Cmax and AUC(0-72h) – as per truncated design; 90% confidence intervals for the T/R ratio of LSM for PPL based on ln-transformed data will be calculated and compared with acceptance limits: AUC(0-72h) 80.00 – 125.00%, Cmax 80.00 – 125.00%.

Secondary Outcomes (1)

tmax

Interventions

Perampanel 2 mg film-coated tabletsType not reported

Fycompa 2 mg film-coated tabletsType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Perampanel 2 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Fycompa 2 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Perampanel 2 mg film-coated tablets
Named ingredient: perampanel
View registry record
Fycompa 2 mg film-coated tablets
Named ingredient: perampanel
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy males and non-pregnant and no breast-feeding females*, ≥ 18 and ≤ 55 years of age** (on the day of Informed Consent). *Women are tested for pregnancy during screening and check-in procedure for each Period. **The upper age limit is set due to higher probability of co-morbidities above 55 years and to avoid unnecessary screening of too many subjects.
Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).

Sponsors & Collaborators

Laboratorios Cinfa S.A.
Industrylead

Study Sites (1)

Quinta-Analytica s.r.o.

Prague 15, 102 00, Czechia

Roman Grunt+420222203222 roman.grunt@quinta.cz

Central Study Contacts

Manuel Vaz

+34677571708 manuel.vaz@cinfa.com

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

March 9, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504132-18-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 03:34:24 UTC

Documents

CTIS Lay People Summary_CFA-1031-2-23_21JUN2024

Acceptance of use of highly effective contraceptive measures during the whole study by female subjects of childbearing potential and contraceptive measures during the whole study by male subjects***. ***Methods of highly effective contraception for female subjects of childbearing potential: - combined (oestrogen and progestogen containing) hormonal contraception, either oral, intravaginal or transdermal or - progestogen-only hormonal contraception associated with inhibition of ovulation, either oral, injectable or implantable or - intrauterine hormone-releasing system or - bilateral tubal occlusion or - vasectomised (sterilised) partner (if it is a sole sexual partner of the subject and medical assessment of the surgical success has been provided to the partner) or - intrauterine device (non-hormonal) since at least 30 days prior to the first dosing and use one of the barrier methods or - abstinence from any sexual intercourse (If this is in line with your preferred and routine lifestyle.) Hormonal intrauterine device or oral hormonal contraceptives or hormonal replacement therapy should be taken without significant changes in dose for 90 days before the first dosing and without change during the study. Highly effective contraception should be combined with use of barrier method with spermicide (condom, diaphragm). Recommended methods of contraception for male subjects: - If a female partner of male participant in the study is of childbearing potential, the couple needs to use the above described highly effective contraception methods. - If a female partner of male participant in the study is pregnant, the recommended contraception method is that the male must use a barrier method (condom). Premenarcheal women, women with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy and postmenopausal women are not considered of childbearing potential. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The appropriate contraceptive measures must be used during this study and at least 30 days after the study completion.

You may not qualify if:

Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
History of significant hypersensitivity to used IMP, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
Serious mental disease and/or inability to cooperate with clinical team.
Abuse of drugs, alcohol (≥ 40 g for men or ≥ 20 g for women of pure ethanol per day), solvents or the inability to give up the consumption of foods containing methylxanthine (such as coffee, tea, mate, cocoa, guarana, cola, energy drinks, chocolate...) in the period from 48 hours before each drug administration until the last blood draw in each study period.
Clinically significant illness within 28 days before the first dosing, including major surgery.
Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment (e.g Saint John´s Wort) and/or food supplements within 14 days before the first dosing.
Any systemic prescription treatment within 28 days before the first dosing, except hormonal contraceptives or substitution taken without significant changes in dose for 90 days prior to the first dosing.
Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing.
Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
Positive urine drugs abuse test result at screening or at check-in.
Positive result of alcohol breath test at screening or at check-in.
Positive result of urine cotinine test at screening.
Female subjects with positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
Body temperature ≥ 37.0 °C at screening or at check-in.
Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
+9 more criteria

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations