NCT00415844

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers

A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 25 mg Carbidopa, 100 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 25 mg Carbidopa and 100 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (planned)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ELC200 (carbidopa+levodopa+entacapone)

Timeline

• Start date: 2006-06-01
• First posted: 2006-12-25
• Last updated: 2007-06-22

Locations

1 site across 1 country: Germany