drugset / Trial / NCT02116465

Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration

NCT02116465

Phase 1 Completed 12 enrolled Desitin Arzneimittel GmbH
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

EvaluationDrugModalityDoseRoute
Comparator Carbidopa Unknown 25 mg Oral
Comparator Levodopa Small molecule 100 mg Oral

Indications

No indication recorded.