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Bioequivalence Study of Perampanel Tablets 12 mg | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioequivalence Study of Perampanel Tablets 12 mg

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

NCT06450223•Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in normal, healthy, adult, human subjects under fasting condition.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study; Willing to be available for the entire study period and to comply protocol requirements;
•Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
•Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
•Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
•Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
•Normal or clinically non-significant 12-lead ECG recording;
•Non-smokers or subjects who have no history of smoking for the last one year prior to check-in;
•Subjects who are willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period;
•Non Alcoholic; Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period;
•Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period;
+2 more criteria

Exclusion Criteria

•Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
•Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
•Any major illness or hospitalized within 90 days prior to the first check-in;
•Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
•Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;
•History or presence of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.The reason for subject discontinuation will be documented in the subject's case report form (CRF).

Locations (1)

Raptim Research Pvt. Ltd.,

Navi Mumbai, India

Key Dates

Start Date

September 14, 2023

Primary Completion Date

September 20, 2023

Completion Date

December 5, 2023

Last Updated

June 12, 2024

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Perampanel 12 MG

DRUG

Fycompa 12 mg film-coated tablets

DRUG

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Epilepsy; Seizure

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RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

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Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence Study of Perampanel Tablets 12 mg

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers