Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Schizophrenia Patients, sponsored by Luye Pharma Group.
NCT04572685 is a Phase 1 study of Schizophrenia Patients that has completed, run by Luye Pharma Group. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Cmax of LY03010 P1, P2 and INVEGA SUSTENNA will be measured
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 |
What the finished NCT04572685 record still lists
NCT04572685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04572685's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI