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

NCT02116465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-04-17

No results posted yet for this study

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.

Conditions

  • Fasted State

Interventions

DRUG

Levodopa Carbidopa immediate release tablets

oral administration

Sponsors & Collaborators

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116465 on ClinicalTrials.gov