Effect of Opicapone Tablets on Levodopa and 3‐O‐Methyldopa Pharmacokinetics in Healthy Japanese Subjects: Phase 1 Study

This study evaluated the effect of a small‐tablet formulation of opicapone for use in clinical trials in Japan on the pharmacokinetics of levodopa (l‐dopa) and 3‐O‐methyldopa (3‐OMD). In an open‐label, 3‐period, single‐sequence crossover phase 1 study in 80 healthy Japanese males (aged 20‐45 years;...

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Veröffentlicht in:	Clinical pharmacology in drug development 2021-02, Vol.10 (2), p.180-189
Hauptverfasser:	Nomoto, Masahiro, Takeda, Atsushi, Iwai, Katsuaki, Nishimura, Akihisa, Hattori, Nobutaka
Format:	Artikel
Sprache:	eng
Schlagworte:	3‐OMD Adult Antiparkinson Agents - administration & dosage Antiparkinson Agents - pharmacokinetics Area Under Curve Asians Carbidopa - administration & dosage Carbidopa - pharmacokinetics Catechol O-Methyltransferase Inhibitors - administration & dosage Catechol O-Methyltransferase Inhibitors - pharmacokinetics COMT inhibitor Cross-Over Studies Dose-Response Relationship, Drug Drug Combinations Half-Life Humans Japanese levodopa Levodopa - administration & dosage Levodopa - pharmacokinetics Male Middle Aged opicapone Original Manuscript Oxadiazoles - administration & dosage Oxadiazoles - pharmacology Parkinson disease Parkinson's disease pharmacokinetic Pharmacokinetics phase 1 Plasma Tablets Tyrosine - analogs & derivatives Tyrosine - pharmacokinetics Young Adult
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Zusammenfassung:	This study evaluated the effect of a small‐tablet formulation of opicapone for use in clinical trials in Japan on the pharmacokinetics of levodopa (l‐dopa) and 3‐O‐methyldopa (3‐OMD). In an open‐label, 3‐period, single‐sequence crossover phase 1 study in 80 healthy Japanese males (aged 20‐45 years; body mass index, 18.5 to
ISSN:	2160-763X 2160-7648
DOI:	10.1002/cpdd.799