Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-23 @ 12:50 PM
Study NCT ID:
NCT02486432
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)
Sponsor:
NeuroDerm Ltd.
Organization:
Study Overview
Official Title:
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach
Detailed Description:
This is a single centre, open-label, single period study in healthy subjects. Each subject will receive the following regimen:
On Day -2, 10 mg domperidone administered every 8 hours 3 times a day (for illustrative purposes, dosing at 07:30, 15:30 and 23:30) On Day -1, 3 doses of 100 mg Sinemet® (every 8 hours) administered as 2 × Sinemet® 12.5 mg/50 mg tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa. Subjects will receive concomitant 10 mg domperidone 30 minutes before every Sinemet® dose.
On Day 1, Sinemet® 12.5 mg/50 mg containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered every hour for 16 consecutive doses (total dose of 800 mg). Subjects will also receive concomitant domperidone up to 20 mg 30 minutes before the first Sinemet® 50 mg dose and every 8 hours (total of 3 doses) after treatment initiation.
It is planned to enrol 6 subjects to ensure there are 6 evaluable subjects. A subject is considered to be evaluable if they have received all 16 Sinemet® 50 mg doses.
On Day -2, 10 mg domperidone administered every 8 hours 3 times a day (for illustrative purposes, dosing at 07:30, 15:30 and 23:30) On Day -1, 3 doses of 100 mg Sinemet® (every 8 hours) administered as 2 × Sinemet® 12.5 mg/50 mg tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa. Subjects will receive concomitant 10 mg domperidone 30 minutes before every Sinemet® dose.
On Day 1, Sinemet® 12.5 mg/50 mg containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered every hour for 16 consecutive doses (total dose of 800 mg). Subjects will also receive concomitant domperidone up to 20 mg 30 minutes before the first Sinemet® 50 mg dose and every 8 hours (total of 3 doses) after treatment initiation.
It is planned to enrol 6 subjects to ensure there are 6 evaluable subjects. A subject is considered to be evaluable if they have received all 16 Sinemet® 50 mg doses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: