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A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

NCT02812394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-10-26

No results posted yet for this study

Summary

This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Conditions

  • Parkinson Disease

Interventions

DRUG

CVT-301 (Dose Level 1)

All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.

DRUG

CVT-301 (Dose Level 2)

All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.

DRUG

Sinemet®

All subjects will receive carbidopa/levodopa tablets administered every 8 hours.

Sponsors & Collaborators

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charles Oh, MD · Acorda Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • United States

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 NCT02812394 on ClinicalTrials.gov