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Research Article: Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial

Date Published: 2023-08-15

Abstract:
Parkinson’s disease (PD) is one of the most common chronic neurodegenerative disorders characterized by progressive degeneration of dopaminergic neurons and Lewy body formation in the substantia nigra, decreased striatal dopamine transmitters, and imbalance of dopamine and acetylcholine transmitters over time, manifested as motor dysfunctions of tremor, disturbance of postural balance, bradykinesia, rigidity, as well as non-motor symptoms including sleep disorders, smell disorders, autonomic dysfunction, cognitive and psychiatric disorders. The major anti-Parkinsonian options available include levodopa and non-ergot dopamine agonists (NEDAs). Although levodopa is the standard therapy for PD and effectively relieves Parkinson’s symptoms, motor complications including symptom fluctuations and dyskinesias may occur along with PD progression and long-term administration of levodopa.– NEDAs showed preferable efficacy and tolerability in several randomized controlled trials when applied as monotherapy for the management of early PD or as first-line adjunct treatment with levodopa for advanced PD, which showed lower incidence of dyskinesia compared with levodopa.,,,

Introduction:
Parkinson’s disease (PD) is one of the most common chronic neurodegenerative disorders characterized by progressive degeneration of dopaminergic neurons and Lewy body formation in the substantia nigra, decreased striatal dopamine transmitters, and imbalance of dopamine and acetylcholine transmitters over time, manifested as motor dysfunctions of tremor, disturbance of postural balance, bradykinesia, rigidity, as well as non-motor symptoms including sleep disorders, smell disorders, autonomic dysfunction, cognitive…

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