NCT03761004

WD-1603 PK Study in Healthy Volunteers

A Phase 1 Single-Dose, Open-label, Sequential, Three-Period Crossover Study to Evaluate the Pharmacokinetics of WD-1603 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hong Kong WD Pharmaceutical Co., Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	carbidopa-levodopa	single dose of WD-1603, BID dose of WD-1603 and Sinemet IR

Timeline

• Start date: 2019-01-14
• Primary completion: 2019-09-05
• Completion: 2019-09-05
• First posted: 2018-12-03
• Last updated: 2020-02-13

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study