Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319170
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-13
Brief Title:
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With SchizophreniaSchizoaffective Disorder
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multi-center Open-label Randomized Parallel-group Trial to Characterize the Pharmacokinetics of Three SC Olanzapine Extended-Release Formulations With Different Release Rates Following Single Administration in Participants With Schizophrenia or Schizoaffective Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine
A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine
Another secondary objective is to characterize the pharmacokinetics of ZYPREXA
The planned duration of the study for each participant is 19 weeks
A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine
Another secondary objective is to characterize the pharmacokinetics of ZYPREXA
The planned duration of the study for each participant is 19 weeks
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None