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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Perampanel 12 MG; Drug: Fycompa 12 mg film-coated tablets

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Navi Mumbai, India
    • Raptim Research Pvt. Ltd.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;
• For female subjects: Negative urine pregnancy test during screening and negative serum β-hCG test at the time of check-in of each study period;
• Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post last-dose / entire study period. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perampanel Tablets; Perampanel Tablets 12mg	Drug: Perampanel 12 MG; 1 tablet of Perampanel Tablets 12 mg
Active Comparator: Fycompa film-coated tablets; Fycompa 12mg film-coated tablets (Perampanel12 mg)	Drug: Fycompa 12 mg film-coated tablets; 1 tablet of Perampanel Tablets 12 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration obtained (Cmax)	two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax	23 hours
AUC from time 0 to last collection time 72 (AUC0-72)	two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-72	23 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of the maximum measured plasma concentration (Tmax)	Description Statistics	23 hours

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: PR/BE/23/229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No