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NCT06319170 · ClinicalTrials.gov registry record · Phase 1
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
A Phase 1 study of Schizophrenia, Schizoaffective Disorder, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 5
- Study locations
NCT06319170 is a Phase 1 study of Schizophrenia, Schizoaffective Disorder that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 106 participants. The trial reports 5 study locations across 4 states.
The verdict
NCT06319170, a Phase 1 study of Schizophrenia, Schizoaffective Disorder, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 5
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Olanzapine Extended Release
- DRUG Olanzapine Immediate Release
Study Locations (5)
Georgia
- Teva Investigational Site 15729 - Atlanta
- Teva Investigational Site 15728 - Decatur
California
- Teva Investigational Site 15730 - Los Alamitos
Florida
- Teva Investigational Site 15727 - Hollywood
New Jersey
- Teva Investigational Site 15726 - Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06319170
The ClinicalTrials.gov registry entry for NCT06319170 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia, Schizoaffective Disorder appearing as the primary indexed condition, and to 2 interventions - of which Olanzapine Extended Release is the first listed.
NCT06319170 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Georgia, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06319170 about?
NCT06319170 is a clinical study titled "Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder". 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...
What is the current status of trial NCT06319170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2024-03-28. Estimated completion is 2025-01-20.
What conditions does trial NCT06319170 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT06319170?
The interventions under investigation include: Olanzapine Extended Release (DRUG), Olanzapine Immediate Release (DRUG).
Who is sponsoring clinical trial NCT06319170?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06319170 being conducted?
This trial has 5 study locations across California, Florida, Georgia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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