MedTrace Logo

Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions

NCT05128175 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-11-19

No results posted yet for this study

Summary

It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.

Conditions

  • Parkinson Disease

Interventions

DRUG

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

For fasting conditions in the morning, a single oral dose will be administered to each subject under fasting conditions before 5 minutes of serving a standardized vegetarian breakfast as per the randomization schedule; for fasting conditions in the afternoon and evening, a single oral dose will be administered to each subject under fasting condition before 5 minutes of serving standardized vegetarian lunch and dinner as per randomization schedule. For fed condition, single oral dose will be administered to each subject after 30 minutes of serving standardized vegetarian breakfast, lunch and dinner as per randomization schedule. Dosing interval between two subsequent dosing should be 5 hours in each period. There will be one tablet for A, B, C, D and E.

Sponsors & Collaborators

  • Shanghai WD Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Akash Patel, M.D. · Lambda Therapeutic Research Ltd.

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
2021-10-29
Primary Completion
2022-01-25
Completion
2022-03-25
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

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 NCT05128175 on ClinicalTrials.gov