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WD-1603 PK Study in Healthy Volunteers

NCT03761004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-13

No results posted yet for this study

Summary

This is a pilot study to investigate if the extended release formulation of WD-1603 generates anticipated plasma concentration profile. The study is an open-label, sequential, 3-way crossover study to evaluate if WD-1603 generates anticipated plasma levodopa exposure compared to Sinemet IR tablets in healthy subjects. The study comprises of a medical Screening visit, three 2-night (3-day) Treatment periods, 2 outpatient visits, and a Follow-up visit. Study drug administration in each Treatment period is separated by a washout interval of 5 days. The Follow-up visit will occur approximately 7 days (±1) following the last study drug administration. The duration of subject participation, including screening, is approximately 6 weeks.

Conditions

  • Healthy Volunteers

Interventions

DRUG

carbidopa-levodopa

single dose of WD-1603, BID dose of WD-1603 and Sinemet IR

Sponsors & Collaborators

  • Hong Kong WD Pharmaceutical Co., Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2019-09-05
Completion
2019-09-05
FDA Drug
Yes

Countries

  • Canada

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 NCT03761004 on ClinicalTrials.gov