Overview

WD-1603 PK Study in Healthy Volunteers

Status:
Completed
Trial end date:
2019-09-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Hong Kong WD Pharmaceutical Co., Limited
Treatments:
Carbidopa
Carbidopa, levodopa drug combination
Levodopa