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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: Completed Phase 1 study of Schizophrenia, Schizoaffective Disorder, sponsored by Teva Branded Pharmaceutical Products R&D.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT06319170 record still lists
NCT06319170 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06319170's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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