Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Early Phase 1CompletedNCT05471609

University of Minnesota6 enrolled

Overview

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

levodopa/carbidopa oral formulation ADRUG

Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD

levodopa/carbidopa oral formulation BDRUG

Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Normal healthy * Are 18-65 years of age * Are not currently taking medications regularly * Able to fast 6 hours (water allowed) Exclusion Criteria: * Pregnancy * Inability to fast

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Carbidopa/levodopa serum level Efficacy of the delivery method

Carbidopa/levodopa serum level

Time frame: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)

Data from ClinicalTrials.gov

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