Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382662
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-20
Brief Title:
Assess the Effect of Metaxalone 640 mg M640 Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition
Sponsor:
Primus Pharmaceuticals
Organization:
Primus Pharmaceuticals
Study Overview
Official Title:
Assessment of the Effect of Metaxalone 640 mg M640 on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg A Prospective Single-blind Within-subject Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Every participant will receive active study drug and one 1 comparator in two 2 stages one after the other Each drug will be taken one 1 time after a high fat meal Vital signs and discussion of medications illness or injury are considered safety assessments and will be discussed at every visit There will be four 4 visits
Detailed Description:
Every participant will receive active study drug and one 1 comparator in two 2 stages one after the other Each drug will be taken one 1 time after a high fat meal Vital signs and discussion of medications illness or injury are considered safety assessments and will be discussed at every visit
The Screening Visit will be followed by the Baseline Visit 1 1-14 days later At the Baseline Visit participants will be given written tests to measure thinking process You will also be asked to take a computer driving simulation test
Visits 2 and 3 approximately one 1 week apart will be the dosing days after eating a high fat meal within 30 minutes The testing from the Baseline Visit will be repeated at four 4 hours and 15 hours after dosing with comparator drug
The End of Study safety visit will take place two 2 weeks later Participants will be given discharge instructions
The Screening Visit will be followed by the Baseline Visit 1 1-14 days later At the Baseline Visit participants will be given written tests to measure thinking process You will also be asked to take a computer driving simulation test
Visits 2 and 3 approximately one 1 week apart will be the dosing days after eating a high fat meal within 30 minutes The testing from the Baseline Visit will be repeated at four 4 hours and 15 hours after dosing with comparator drug
The End of Study safety visit will take place two 2 weeks later Participants will be given discharge instructions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None