Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474799
Status:
COMPLETED
Last Update Posted:
2008-01-14
First Post:
2007-05-15
Brief Title:
Study to Assess the Safety Tolerability and Pharmacokinetic Profile of MNS075 Intranasal Morphine
Sponsor:
Javelin Pharmaceuticals
Organization:
Javelin Pharmaceuticals
Study Overview
Official Title:
An Open Label Randomized Single Center Repeat Dose Study to Assess the Safety Tolerability and Pharmacokinetic Profile of MNS075 Intranasal Morphine in Opioid naïve Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2008-01
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:
The purpose of this study is to characterize the repeat dosing plasma profile extent of accumulation and repeat dose pharmacokinetics of morphine morphine-3-glucuronide and morphine-6-glucuronide during administration of MNS075 in two different clinically-relevant dosing schedules
Detailed Description:
This study is an open label randomized two-treatment two-period two-sequence single-center crossover study comparing the pharmacokinetics safety and tolerability of MNS075 intranasal morphine at doses of 75 mg self-administered q1h for 7 hours 8 doses and 15 mg self-administered q3h for 9 hours 4 doses
Study Oversight
Has Oversight DMC:
None
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?:
None