[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-410405-105":59,"doc-detail-410405-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","bioequivalence-of-two-perampanel-oral-suspension-formulationsin-healthy-subjects-a-randomized-crossover-study","Bioequivalence of Two Perampanel Oral Suspension Formulationsin Healthy Subjects - A Randomized Crossover Study","","Perampanel, approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, is available as an oral suspension to support patients who cannot swallow tablets. Limited affordable generic options motivated evaluation of a cheaper bioequivalent formulation. A two-period, open-label crossover study under fasting conditions compared test and reference perampanel oral suspensions (0.5 mg/mL) in healthy subjects.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/bioequivalence-of-two-perampanel-oral-suspension-formulationsin-healthy-subjects-a-randomized-crossover-study/410405/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/bioequivalence-of-two-perampanel-oral-suspension-formulationsin-healthy-subjects-a-randomized-crossover-study/410405.png","ImageObject",300,407,{"name":92,"@type":93},"\tCallum ","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-28",true,{"@type":102,"interactionType":103,"userInteractionCount":29},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main objective of the study?","Question",{"text":112,"@type":113},"To assess the bioequivalence of two perampanel oral suspension formulations (0.5 mg/mL) administered under fasting conditions as an affordable alternative.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was bioequivalence evaluated?",{"text":117,"@type":113},"Primary pharmacokinetic parameters were maximum concentration (Cmax) and area under the concentration–time curve up to 72 hours (AUC0-72), using the geometric mean ratio and 90% confidence intervals.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the study results and safety findings?",{"text":121,"@type":113},"Geometric mean ratios and 90% confidence intervals for Cmax and AUC0-72 were within the 80–125% bioequivalence range. Adverse events were mild, mainly headache and dizziness.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},410405,1790719044,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":29,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},137451211410,"https://ap-avatar.wpscdn.com/avatar/2000bb0a9246f588df?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786362646172706240","Drugs in R&D (2025) 25:343–351  \n[https://doi.org/10.1007/s40268-025-00526-5](https://doi.org/10.1007/s40268-025-00526-5)  \nBioequivalence of Two Perampanel Oral Suspension Formulationsin Healthy Subjects: A Randomized Crossover Study  \nAya M. AbdelMagid1 · Kamal A. Badr2,3 · Mamdouh R. Rezk4  \nReceived: 19 May 2025 / Accepted: 5 October 2025 / Published online: 18 November 2025 © The Author(s) 2025  \nAbstract  \nBackground and Objective Perampanel has been approved for the adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures. The oral suspension formulation benefits patients who have difficulty swallowing tablets. The unavailability of an affordable generic perampanel oral suspension formulation increased the need for a cheaper bioequivalent alternative to the marketed reference product. The study aimed to assess the bioequivalence of two formulations of perampanel oral suspension (0.5 mg/mL) administered under fasting conditions focusing on providing a cost-effective and accessible alternative to current formulations.  \nMethods This was an open-label, two-period, two-sequence, crossover, bioequivalence study conducted under fasting conditions. Healthy subjects were randomized to receive single doses of perampanel oral suspension (12 mg), Lepsiramp and Fycompa® separated by a 6-week washout period. The maximum concentration and area under the concentration–time curve up to 72 h were the primary pharmacokinetic parameters used to assess bioequivalence.  \nResults The geometric mean ratio of test to reference formulations and 90% confidence interval were 109.55 (99.49–120.64) for maximum concentration and 98.15 (90.68–106.23) for the area under the concentration–time curve up to 72 h which  \n,  \nwere within the 80–125% bioequivalence range. The adverse events were mild headache and dizziness.  \nConclusions The two oral suspension formulations were bioequivalent, safe, and well tolerated. This provides a beneficial affordable alternative for patients requiring non-tablet oral formulations.  \nClinical Trial Registration [The ClinicalTrials.gov](The ClinicalTrials.gov) registration number is NCT06969963, retrospectively registered on 13 May, 2025.  \n* Aya M. AbdelMagid[aya.abdelmagid@pharma.cu.edu.eg](aya.abdelmagid@pharma.cu.edu.eg)  \nKamal A. Badr  \n[dr.kamal.badr@gmail.com](dr.kamal.badr@gmail.com)  \nMamdouh R. Rezk  \n[mamdouh.rezk@pharma.cu.edu.eg](mamdouh.rezk@pharma.cu.edu.eg)  \n1 Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., P.O. Box: 11562, Cairo, Egypt  \n2 Advanced Research Center (ARC), Nasr City, Cairo, Egypt  \n3 Pharmaceutics Department, Faculty of Pharmacy, Deraya University, New Minya, Egypt  \n4 Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt  \n1 Introduction  \nEpilepsy is a chronic non-communicable brain disease that affects approximately 50 million people worldwide. Most affected patients live in low-to-middle income countries and suffer from multiple psychological, physical, and social  \nconsequences, making the disease a significant health burden [1, 2] . Perampanel, a third-generation anticonvulsant, is classified as an AMPA receptor antagonist that targets α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors [3] . In 2012, the drug was approved in the USA as a once-daily oral therapy (adjunctive and monotherapy) for the management of focal-onset seizures with or without secondarily generalized seizures for patients with epilepsy aged 4 years and more in addition to its use as adjunctive therapy for primary generalized tonic-clonic seizures inpatients aged 12 years and more [1, 4, 5] .  \nFollowing oral administration, perampanel is readily absorbed without marked first-pass metabolism. Despite the administration of perampanel tablets with a highfat meal having no impact on both the peak plasma concentration (Cmax) and the total exposure (area under the plasma concentration–","cbCaieJgMYEjZDy1","https://ap.wps.com/l/cbCaieJgMYEjZDy1","pdf",778824,"English","# Abstract\n## Background and Objective\n## Methods\n## Results\n## Conclusions\n# Introduction\n## Study Rationale\n## Pharmacokinetic Background\n# Methods\n## Study Population","[{\"question\":\"What was the main objective of the study?\",\"answer\":\"To assess the bioequivalence of two perampanel oral suspension formulations (0.5 mg/mL) administered under fasting conditions as an affordable alternative.\"},{\"question\":\"How was bioequivalence evaluated?\",\"answer\":\"Primary pharmacokinetic parameters were maximum concentration (Cmax) and area under the concentration–time curve up to 72 hours (AUC0-72), using the geometric mean ratio and 90% confidence intervals.\"},{\"question\":\"What were the study results and safety findings?\",\"answer\":\"Geometric mean ratios and 90% confidence intervals for Cmax and AUC0-72 were within the 80–125% bioequivalence range. Adverse events were mild, mainly headache and dizziness.\"}]","Bioequivalence of Two Perampanel Oral Suspension Formulationsin Healthy Subjects - A Randomized Crossover Study | PDF",1790585201,23]