Trials / Completed
CompletedNCT00415831
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 12.5 mg Carbidopa, 50 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 12.5 mg Carbidopa and 50 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fed 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 fed conditions in healthy volunteers.
Conditions
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
Source: ClinicalTrials.gov record NCT00415831. Inclusion in this directory is not an endorsement.