The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.
IPX054 contains two different drugs called levodopa and carbidopa in one tablet. * levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease. * carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IPX054 containing 25 mg carbidopa and 100 mg levodopa
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
Site 101
Sunnyvale, California, United States
Site 102
Lawrence, Kansas, United States
Parkinsonian disability at Visits 1 and 5
Time frame: 36 Days
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CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa