drugset / Trial / NCT02116465
Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration
RandomizedCrossoverOpen-label
Summary
The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg). Additionally, to describe and compare the safety and tolerability of the two investigational treatments administered to healthy subjects.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbidopa | Unknown | 25 mg | Oral |
| Comparator | Levodopa | Small molecule | 100 mg | Oral |
Indications
No indication recorded.