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

NCT04572685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-11-09

No results posted yet for this 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

  • Schizophrenia Patients

Interventions

DRUG

Paliperidone Palmitate

A long acting extended release injectable suspension intended for monthly intramuscular administration

Sponsors & Collaborators

  • Alliance for Clinical Trials in Oncology

    collaborator OTHER

  • Evolution Research Group

    collaborator NETWORK

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Luye Pharma · Luye Pharma Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2020-06-26
Completion
2020-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572685 on ClinicalTrials.gov