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PK Study of WD-1603 in Healthy Subjects

NCT04591535 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

Sponsors & Collaborators

  • Hong Kong WD Pharmaceutical Co., Limited

    lead INDUSTRY

Principal Investigators

  • Shrikrishna Kolte, Doctor · Lambda Therapeutic Research Limited, Ahmedabad,India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-03-28
Completion
2021-03-28
FDA Drug
Yes

Countries

  • India

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 NCT04591535 on ClinicalTrials.gov