The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.
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
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Quest Research Institute
Bingham Farms, Michigan, United States
Oregon Health Sciences University - Parkinson's Center of Oregon
Portland, Oregon, United States
Alternate tapping of keys
Time frame: single dose
Timed walking
Time frame: single dose
Tremor score
Time frame: single dose
Dyskinesia rating scale
Time frame: single dose
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Active comparator containing 50 mg carbidopa and 200 mg levodopa
Placebo to match IPX054 200 mg
Placebo to match IPX054 250 mg
Placebo to match CD-LD IR
Placebo to match CD-LD CR