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NCT04572685 · ClinicalTrials.gov registry record · Phase 1
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
A Phase 1 study of Schizophrenia Patients, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04572685 is a Phase 1 study of Schizophrenia Patients that has completed, run by Luye Pharma Group. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04572685, a Phase 1 study of Schizophrenia Patients, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Conditions Studied
Interventions
- DRUG Paliperidone Palmitate
Study Locations (1)
New Jersey
- Hassman Research Institute - Berlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04572685
The ClinicalTrials.gov registry entry for NCT04572685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Luye Pharma Group, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia Patients appearing as the primary indexed condition, and to 1 intervention - of which Paliperidone Palmitate is the first listed.
NCT04572685 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT04572685 about?
NCT04572685 is a clinical study titled "Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients". The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg ...
What is the current status of trial NCT04572685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-01-22. Estimated completion is 2020-08-20.
What conditions does trial NCT04572685 study?
This clinical trial studies the following conditions: Schizophrenia Patients.
What interventions are being tested in trial NCT04572685?
The interventions under investigation include: Paliperidone Palmitate (DRUG).
Who is sponsoring clinical trial NCT04572685?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572685 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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