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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WD-1603 single dose | Experimental | 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. |
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| WD-1603 BID dose | Experimental | 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. |
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| Sinemet single dose | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbidopa-levodopa | Drug | single dose of WD-1603, BID dose of WD-1603 and Sinemet IR |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | the maximum plasma concentrations | 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 | 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 | pre-dose(baseline)and specified time points up to 24 hours post-dose(as specified in the Arm/Group description) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INC Research Toronto, Inc. | Toronto | Canada |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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