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NCT06315283 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT06315283: Completed Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT06315283 is a Phase 1 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315283, a Phase 1 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia. Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. The total duration of participation in the trial for each participant is planned to be approximately 21 weeks.
Interventions
- DRUG TV-44749
- DRUG Oral olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2024-03-20 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 1 |
What the finished NCT06315283 record still lists
NCT06315283 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (155% higher).
The record links to 0 conditions, and to 2 interventions - of which TV-44749 is the first listed.
NCT06315283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06315283 about?
NCT06315283 is a clinical study titled "An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia". The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. A secondary objective of this trial is to evaluate the safety and tolerability of multiple d...
What is the current status of trial NCT06315283?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2024-03-20. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT06315283?
The interventions under investigation include: TV-44749 (DRUG), Oral olanzapine (DRUG).
Who is sponsoring clinical trial NCT06315283?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06315283's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 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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