Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600477
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
A Study of Olanzapine After Intranasal and Intramuscular Administration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Randomized Single Dose Three-Arm Parallel Open-Label Study to Characterize the Pharmacokinetics of 75 Mg Olanzapine Intranasal Spray and 75 Mg Olanzapine Intramuscular Injection After Administration to Healthy Male Adults Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NRL-4 a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc for use as a rescue medication for acute episodes of agitation in schizophrenia schizoaffective and bipolar I disorder Also being tested are different concentrations of Intravail A3 Intravail A3 belongs to a class of nonionic surfactants known as alkylglycosides Alkylglycosides have been extensively studied for their ability to promote increased bioavailability of drugs via the nasal oral and ocular routes
In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax AUC from time 0 to time t and AUC from time 0 to infinity and safety assessments including nasal irritation sedation and pain scales
In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax AUC from time 0 to time t and AUC from time 0 to infinity and safety assessments including nasal irritation sedation and pain scales
Detailed Description:
None
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