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Pharmacokinetics of...
Pharmacokinetics of Intravenously (DIZ101), Subcutaneously (DIZ102), and Intestinally (LCIG) Infused Levodopa in Advanced Parkinson Disease
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- Bergquist, Filip (author)
- University of Gothenburg,Sahlgrenska University Hospital
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- Ehrnebo, Mats (author)
- Uppsala University,Uppsala universitet,Institutionen för farmaceutisk biovetenskap,Uppsala Univ, Sweden; Pharm Assist Sweden AB, Sweden
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- Nyholm, Dag, Professor, 1974- (author)
- Uppsala University,Uppsala universitet,Landtblom: Neurovetenskap,Uppsala Univ, Sweden
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- Johansson, Anders (author)
- Karolinska Institutet,Karolinska Institute
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- Lundin, Fredrik (author)
- Linköping University,Linköpings universitet,Avdelningen för neurobiologi,Medicinska fakulteten,Region Östergötland, Neurologiska kliniken i Linköping,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.
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- Odin, Per (author)
- Lund University,Lunds universitet,Restorative Parkinson Unit,Forskargrupper vid Lunds universitet,Lund University Research Groups
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- Svenningsson, Per (author)
- Karolinska Institute
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- Hansson, Fredrik (author)
- CTC Clin Trial Consultants AB, Uppsala, Sweden.,Clinical Trial Consultants AB
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- Bring, Leif (author)
- Dizlin Pharmaceut, Gothenburg, Sweden.,Dizlin Pharmaceuticals AB
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- Eriksson, Elias (author)
- University of Gothenburg
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- Dizdar Segrell, Nil (author)
- Linköping University,Linköpings universitet,Avdelningen för neurobiologi,Medicinska fakulteten,Region Östergötland, Neurologiska kliniken i Linköping,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.
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(creator_code:org_t)
- Lippincott, Williams & Wilkins, 2022
- 2022
- English.
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In: Neurology. - : Lippincott, Williams & Wilkins. - 0028-3878 .- 1526-632X. ; 99:10, s. E965-E976
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Abstract
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- Background and Objectives Intestinal levodopa/carbidopa gel infusion (LCIG) is superior to oral treatment in advanced Parkinson disease. The primary objective of this trial was to investigate whether continuous subcutaneous or intravenous infusion with a continuously buffered acidic levodopa/carbidopa solution yields steady-state plasma concentrations of levodopa that are equivalent in magnitude, and noninferior in variability, to those obtained with LCIG in patients with advanced Parkinson disease. Methods A concentrated acidic levodopa/carbidopa (8:1) solution buffered continuously and administered intravenously (DIZ101) or subcutaneously (DIZ102) was compared with an approved LCIG in a randomized, 3-period crossover, open-label, multicenter trial. Formulations were infused for 16 hours to patients with Parkinson disease who were using LCIG as their regular treatment. Patients were recruited from several university neurology clinics but came to the same phase I unit for treatment. Pharmacokinetic variables and safety including dermal tolerance are reported. The primary outcomes were bioequivalence and noninferior variability of DIZ101 and DIZ102 vs LCIG with respect to levodopa plasma concentrations. Results With dosing adjusted to estimated bioavailability, DIZ101 and DIZ102 produced levodopa plasma levels within standard bioequivalence limits compared with LCIG in the 18 participants who received all treatments. Although the levodopa bioavailability for DIZ102 was complete, it was 80% for LCIG. Therapeutic concentrations of levodopa were reached as quickly with subcutaneous administration of DIZ102 as with LCIG and remained stable throughout the infusions. Owing to poor uptake of LCIG, carbidopa levels in plasma were higher with DIZ101 and DIZ102 than with the former. All individuals receiving any of the treatments (n = 20) were included in the evaluation of safety and tolerability. Reactions at the infusion sites were mild and transient. Discussion It is feasible to rapidly achieve high and stable levodopa concentrations by means of continuous buffering of a subcutaneously administered acidic levodopa/carbidopa-containing solution.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Neurology
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- By the author/editor
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Bergquist, Filip
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Ehrnebo, Mats
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Nyholm, Dag, Pro ...
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Johansson, Ander ...
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Lundin, Fredrik
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Odin, Per
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Svenningsson, Pe ...
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Hansson, Fredrik
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Bring, Leif
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Eriksson, Elias
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Dizdar Segrell, ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
- Articles in the publication
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Neurology
- By the university
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Linköping University
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Uppsala University
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Lund University
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Karolinska Institutet