Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGlevodopa/carbidopa oral formulation A
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
DRUGlevodopa/carbidopa oral formulation B
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
2 different assemblies with 2 different formulations (A, B) will be used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carbidopa/levodopa serum level Efficacy of the delivery method | 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples) | Carbidopa/levodopa serum level |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKhalaf Bushara, MD,FRCP
University of Minnesota
Outcome results
None listed