NCT00869791

A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

Detailed description

This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms \[ECGs\], clinical laboratory tests, vital signs, adverse events \[AEs\], and concomitant medications) were evaluated over the course of the study.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	IPX066	experimental drug product: extended-release carbidopa-levodopa capsules
DRUG	IR CD-LD	active comparator: immediate-release carbidopa-levodopa capsules

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-03-26
• Last updated: 2019-11-08
• Results posted: 2017-03-31

Locations

1 site across 1 country: United States