Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00239564|
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : February 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Drug: IPX054 100 mg Drug: IPX054 150 mg Drug: IPX054 200 mg Drug: IPX054 250 mg Drug: IPX054 300 mg||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Experimental: Experimental: carbidopa and levodopa
Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.
Drug: IPX054 100 mg
IPX054 containing 25 mg carbidopa and 100 mg levodopa
Other Name: CD-LD ER 100 mgDrug: IPX054 150 mg
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
Other Name: CD-LD ER 150 mgDrug: IPX054 200 mg
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
Other Name: CD-LD ER 200 mgDrug: IPX054 250 mg
CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
Other Name: CD-LD ER 250 mgDrug: IPX054 300 mg
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
Other Name: CD-LD ER 300 mg
- Parkinsonian disability at Visits 1 and 5 [ Time Frame: 36 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239564
|United States, California|
|Sunnyvale, California, United States, 94089|
|United States, Kansas|
|Lawrence, Kansas, United States, 66045|
|Study Director:||Impax||Impax Pharmaceuticals, a division of Impax Laboratories|