Overview

Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients

Status:
Completed

Trial end date:
2020-08-20

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Luye Pharma Group Ltd.

Collaborators:

Alliance for Clinical Trials in Oncology
Evolution Research Group

Treatments:

Paliperidone Palmitate