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NCT01094249 · ClinicalTrials.gov registry record · Phase 1
A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder
A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01094249 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 9 participants.
The verdict
NCT01094249, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder.
Interventions
- DRUG divalproex sodium ER/paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01094249
The ClinicalTrials.gov registry entry for NCT01094249 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which divalproex sodium ER/paliperidone ER is the first listed.
NCT01094249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01094249 about?
NCT01094249 is a clinical study titled "A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder". The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder.
What is the current status of trial NCT01094249?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-02. Estimated completion is 2009-04.
What interventions are being tested in trial NCT01094249?
The interventions under investigation include: divalproex sodium ER/paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT01094249?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
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