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Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
NCT06319170 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06319170 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Georgia, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06319170?
The interventions under investigation include: Olanzapine Extended Release (DRUG), Olanzapine Immediate Release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06319170?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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