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1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel

Trial Profile

1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Levodopa/carbidopa (Primary) ; Levodopa/carbidopa
  • Indications Parkinson's disease
  • Focus Pharmacokinetics
  • Sponsors NeuroDerm
  • Most Recent Events

    • 27 Apr 2023 Results (n=16) assessing relative bioavailability of levodopa when administered as a subcutaneous (SC) levodopa/carbidopa (LD/CD) infusion with ND0612 versus levodopa derived from oral immediate-release LD/CD (IR-LD/CD) tablets in healthy volunteers, presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
    • 16 Sep 2020 Results assessing population pharmacokinetic analysis of levodopa and carbidopa in two phase 1 studies of ND0612 (NCT04006210 & NCT02604914), presented at the 24th International Congress of Parkinson's Disease and Movement Disorders.
    • 08 Jun 2017 Pooled results from two open-label, dose-finding studies assessing optimal carbidopa concentration in subcutaneously administered ND0612, presented at the 69th Annual Meeting of the American Academy of NeurologyResults presented at the 21st International Congress of Parkinson's Disease and Movement Disorders
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