NCT03751488

A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients

A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Determine the Relative Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood of Schizophrenia Patients

Conditions

• Schizo Affective Disorder
• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	LY03010	Single Dose of LY03010 at 351 mg or 156 mg or 117mg
DRUG	Invega Sustenna 156 MG in 1 ML Prefilled Syringe	Single Dose at 156mg

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-07-24
• Completion: 2019-07-24
• First posted: 2018-11-23
• Last updated: 2019-08-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study