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NCT01592110 · ClinicalTrials.gov registry record · Phase 1
A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia
A Phase 1 study, sponsored by Zogenix.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01592110 is a Phase 1 study that has completed, run by Zogenix. The registered enrollment target is 40 participants.
The verdict
NCT01592110, a Phase 1 study, has completed, sponsored by Zogenix.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
Interventions
- DRUG risperidone-SABER
- OTHER ZX003:risperidone-SABER and the DosePro System
- DRUG Risperidone-SABER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592110
The ClinicalTrials.gov registry entry for NCT01592110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which risperidone-SABER is the first listed.
NCT01592110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01592110 about?
NCT01592110 is a clinical study titled "A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia". This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
What is the current status of trial NCT01592110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-07. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01592110?
The interventions under investigation include: risperidone-SABER (DRUG), ZX003:risperidone-SABER and the DosePro System (OTHER), Risperidone-SABER (DRUG).
Who is sponsoring clinical trial NCT01592110?
This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.
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