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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 is a Phase 1 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 153 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06315283
The ClinicalTrials.gov registry entry for NCT06315283 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 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 0 conditions, and to 2 interventions - of which TV-44749 is the first listed.
NCT06315283 reports 0 study locations.
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.
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