Trials / Completed
CompletedNCT03055936
Dose-finding Pharmacokinetic Study in Healthy Males
A Dose-finding Study for Levodopa, Carbidopa and ODM-104 Test Formulations After Repeated Administration in Healthy Males
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a phase I PK study in healthy males.
Detailed description
This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levodopa | Levodopa 50 mg or 100 mg or 150 mg |
| DRUG | Carbidopa | Carbidopa 12.5 mg or 25 mg or 65 mg |
| DRUG | ODM-104 | ODM-104 50 mg or 100 mg |
Timeline
- Start date
- 2017-02-21
- Primary completion
- 2017-06-09
- Completion
- 2017-06-09
- First posted
- 2017-02-16
- Last updated
- 2021-05-27
- Results posted
- 2021-05-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03055936. Inclusion in this directory is not an endorsement.