[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-432024-105":3,"detail-sidebar-cat-0-en-105":84,"doc-detail-432024-en":134},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":77,"head_meta":79,"extra_data":81,"updated_unix":83},105,"en","bioequivalence-of-foslevodopafoscarbidopa-continuous-subcutaneous-infusion-to-arm-thigh-or-flank-versus-abdomen-in-healthy-and-advanced-parkinsons-disease-individuals","Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson’s disease individuals","","Foslevodopa/foscarbidopa (LDp/CDp) are soluble prodrugs of levodopa/carbidopa delivered as continuous subcutaneous infusion (CSCI) via a portable pump to provide continuous levodopa exposure. Safety and relative bioavailability were evaluated after 24-hour CSCI to the arm, thigh, and flank versus the abdomen in healthy volunteers and adults with advanced Parkinson’s disease. Two open-label randomized crossover studies assessed pharmacokinetics, and the 90% confidence intervals for AUC and Cmax met bioequivalence criteria. Mild infusion site reactions were most common, with no serious events or early discontinuations.",{"@graph":14,"@context":76},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/research-report/","Research & Report",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/bioequivalence-of-foslevodopafoscarbidopa-continuous-subcutaneous-infusion-to-arm-thigh-or-flank-versus-abdomen-in-healthy-and-advanced-parkinsons-disease-individuals/432024/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/bioequivalence-of-foslevodopafoscarbidopa-continuous-subcutaneous-infusion-to-arm-thigh-or-flank-versus-abdomen-in-healthy-and-advanced-parkinsons-disease-individuals/432024.png","ImageObject",300,407,{"name":42,"@type":43},"Stanley","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-09-30","2026-09-29",true,{"@type":52,"interactionType":53,"userInteractionCount":22},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68,72],{"name":59,"@type":60,"acceptedAnswer":61},"What was the primary objective of the studies?","Question",{"text":62,"@type":63},"To assess the safety of LDp/CDp and the relative bioavailability of levodopa/carbidopa after 24-hour CSCI delivered to the arm, thigh, and flank versus the abdomen.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"How were the pharmacokinetic comparisons performed across infusion sites?",{"text":67,"@type":63},"Two open-label randomized crossover studies evaluated 24-hour CSCI regimens at different sites. Bioequivalence was concluded when 90% confidence intervals for AUC and Cmax fell within the 80–125% range for abdomen versus each alternate site.",{"name":69,"@type":60,"acceptedAnswer":70},"What adverse events were most commonly reported?",{"text":71,"@type":63},"The most commonly reported treatment-emergent adverse events were mild infusion site reactions, occurring in 3/12 participants in the healthy volunteer study and 9/16 in the advanced Parkinson’s disease study.",{"name":73,"@type":60,"acceptedAnswer":74},"Did the study identify any serious safety concerns or early discontinuations?",{"text":75,"@type":63},"No serious treatment-emergent adverse events were reported, and no event led to early discontinuation in either study.","https://schema.org",{"og:url":32,"og:type":78,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":80,"canonical":32},"index,follow",{"doc_id":82,"site_id":7},432024,1790794711,{"code":4,"msg":85,"data":86},"success",[87,91,95,99,104,109,114,118,123,126,130],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":88,"show_sort_weight":89,"slug":90},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":92,"show_sort_weight":93,"slug":94},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},"Exam",70,"exam",{"id":100,"doc_module":4,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},5,"Comic",60,"comic",{"id":105,"doc_module":4,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},6,"Technology",50,"technology",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},7,"Healthcare",40,"healthcare",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":116,"slug":117},8,30,"research-report",{"id":119,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},9,"Religion & Spirituality",20,"religion-spirituality",{"id":121,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":121,"slug":125},"World Cup","world-cup",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":127,"slug":129},10,"Lifestyle","lifestyle",{"id":131,"doc_module":4,"doc_module_name":25,"category_name":132,"show_sort_weight":100,"slug":133},19,"General","general",{"code":4,"msg":85,"data":135},{"doc_id":82,"user_id":136,"nickname":42,"user_avatar":137,"doc_module":4,"category_id":115,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":138,"file_id":139,"file_url":140,"file_type":141,"file_size":142,"view_count":22,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":110,"language":143,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":144,"faqs":145,"seo_title":146,"seo_description":12,"update_tm":147,"read_time":148},2336477405376,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","PRDOA 13 (2025) 100359  \nContents lists available at ScienceDirect  \nClinical Parkinsonism & Related Disorders  \njournal [homepage:](homepage: www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders)[ www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders](homepage: www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders)  \n| Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson’s disease individuals |  |  | |\n| --- | --- | --- | --- |\n| Yi Rang Hana,*, Anna Jeong a, Kanwal Ayub a, Shelly V. Gupta a, Lars Bergmanna, Drew S. Kern b, Fernando Pagan c, Matthew Rosebraugha\u003Cbr>a AbbVie, Inc., North Chicago, IL, USA\u003Cbr>b Departments of Neurology and Neurosurgery, University of Colorado School of Medicine, Aurora, CO, USAc Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA |  |  |  |\n| A R T I C L E I N F O |  | A B S T R A C T |  |\n| Keywords: Levodopa Carbidopa\u003Cbr>Advanced Parkinson’s disease\u003Cbr>Subcutaneous infusions Pharmacokinetics Prodrugs Bioequivalence Bioavailability Subcutaneous levodopa Infusion therapies |  | Background: Foslevodopa/foscarbidopa (LDp/CDp) are soluble prodrugs of levodopa/carbidopa delivered as a continuous subcutaneous infusion (CSCI) via a portable pump to provide continuous levodopa exposures. Objective: To assess the safety of LDp/CDp and the relative bioavailability of levodopa/carbidopa following LDp/ CDp 24-hour CSCI administration to the arm, thigh, and flank versus the abdomen.\u003Cbr>Methods: Two open-label, randomized crossover studies (healthy adult volunteers [HV]; adults with advanced Parkinson’s disease [aPD]; NCT05094050) evaluated 24-hr CSCI of LDp/CDp to different infusion sites (abdomen, arm, thigh, flank), each designated as a study regimen. Participants in the aPD study had levodoparesponsive idiopathic Parkinson’s disease with ≥2.5 h of “Off” time/day. In the HV study, each LDp/CDp regimen was administered over 24 h, with 72-hour washout periods between regimens. In the aPD study, LDp/ CDp was administered for 2 consecutive days at each infusion site, with no washout between regimens. Results: For both levodopa and carbidopa, the 90% confidence intervals for both exposure measures (AUC and C max) were within the 80–125% range for the comparison between the abdomen and each alternate infusion site, meeting the criteria for bioequivalence. The most commonly reported treatment-emergent adverse events (TEAEs) were mild infusion site reactions, which occurred in 3/12 participants (HV study) and 9/16 participants (aPD study). There were no serious TEAEs and no event led to early discontinuation in either study. Conclusions: The pharmacokinetics of levodopa and carbidopa demonstrated that the abdomen, arm, thigh, and flank are interchangeable sites for CSCI of LDp/CDp. There were no concerning patterns of adverse events. |  |\n\n1. Introduction  \nDopamine replacement with oral levodopa preparations is the mainstay of treatment for Parkinson’s disease (PD) [1,2]. These standard levodopa preparations are typically co-administered with oral carbidopa, an aromatic amino acid decarboxylase inhibitor that minimizes the peripheral conversion of levodopa to dopamine [1,3], thus enhancing the amount of levodopa available to cross the blood brain barrier, where it is converted into dopamine [1,3–5]. Neither dopamine nor carbidopa crosses the blood brain barrier [4].  \nThere is currently no cure or disease modifying agent available for the management of PD [6]. Thus, the therapeutical goal of PD treatment  \nis symptomatic relief and improving quality of life [1]. As PD worsens from its early stages to advanced disease, a combination of progressive nigrostriatal dopaminergic denervation and unreliable absorption of oral levodopa medications may lead to disabling motor and non-motor symptoms [5,7]. Para","cbCaiaZlUUk9p3yJ","https://ap.wps.com/l/cbCaiaZlUUk9p3yJ","pdf",2915781,"English","# Introduction\n## Background on oral levodopa and carbidopa\n## Rationale for alternate infusion delivery systems\n# Methods\n## Study design in healthy volunteers and advanced Parkinson’s disease\n## Infusion sites and dosing schedule\n# Results\n## Bioequivalence of exposure measures (AUC and Cmax)\n## Safety and treatment-emergent adverse events\n# Conclusions","[{\"question\":\"What was the primary objective of the studies?\",\"answer\":\"To assess the safety of LDp/CDp and the relative bioavailability of levodopa/carbidopa after 24-hour CSCI delivered to the arm, thigh, and flank versus the abdomen.\"},{\"question\":\"How were the pharmacokinetic comparisons performed across infusion sites?\",\"answer\":\"Two open-label randomized crossover studies evaluated 24-hour CSCI regimens at different sites. Bioequivalence was concluded when 90% confidence intervals for AUC and Cmax fell within the 80–125% range for abdomen versus each alternate site.\"},{\"question\":\"What adverse events were most commonly reported?\",\"answer\":\"The most commonly reported treatment-emergent adverse events were mild infusion site reactions, occurring in 3/12 participants in the healthy volunteer study and 9/16 in the advanced Parkinson’s disease study.\"},{\"question\":\"Did the study identify any serious safety concerns or early discontinuations?\",\"answer\":\"No serious treatment-emergent adverse events were reported, and no event led to early discontinuation in either study.\"}]","Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson’s disease individuals | PDF",1790657713,18]