A Phase 1 interventional study of carbidopa-levodopa in Healthy Volunteers, sponsored by Hong Kong WD Pharmaceutical Co., Limited. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Hong Kong WD Pharmaceutical Co., Limited · Phase 1, Interventional, and Treatment
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.
Hong Kong WD Pharmaceutical Co., Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
WD-1603 single dose: A single WD-1603 tablet after breakfast. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 16 and 24 hours post-dose.
Drug: carbidopa-levodopa
WD-1603 BID dose: A single WD-1603 tablet after breakfast, and a second WD-1603 tablet approximately 3 hours after completing lunch. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 4.5, 5, 6, 7, 7.25, 7.5, 7.75, 8, 8.5, 9, 10, 10.5 11, 12, 16 and 24 hours post-dose.
Drug: carbidopa-levodopa
Sinemet single dose: A single oral dose of Sinemet after breakfast. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 16 and 24 hours post-dose.
Drug: carbidopa-levodopa
single dose of WD-1603, BID dose of WD-1603 and Sinemet IR
Cmax
the maximum plasma concentrations
Time frame: pre-dose(baseline)and specified time points up to 24 hours post-dose(as specified in the Arm/Group description)
AUC0-t
the areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation
Time frame: pre-dose(baseline)and specified time points up to 24 hours post-dose(as specified in the Arm/Group description)
AUC0-inf
the areas under the plasma concentration versus time curve extrapolated from 0 to infinity
Time frame: pre-dose(baseline)and specified time points up to 24 hours post-dose(as specified in the Arm/Group description)
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hong Kong WD Pharmaceutical Co., Limited