NCT04591535

PK Study of WD-1603 in Healthy Subjects

An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Hong Kong WD Pharmaceutical Co., Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. A single oral dose of (either Treatment A or B or C or D) carbidopa/levodopa extended release tablets will be administered to each subject within 5 minutes after completion of standardized vegetarian breakfast under fed condition in each period as per randomization schedule.

Detailed description

This is an open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. A single oral dose of (either Treatment A or B or C or D) carbidopa/levodopa extended release tablets will be administered to each subject within 5 minutes after completion of standardized vegetarian breakfast under fed condition in each period as per randomization schedule.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS	WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-03-28
• Completion: 2021-03-28
• First posted: 2020-10-19
• Last updated: 2020-10-19

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study