MedTrace Logo

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

NCT02174510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-01-11

Study results available
· View outcomes & findings →

Summary

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Conditions

Interventions

DRUG

20mg lurasidone

single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

DRUG

40mg lurasidone

single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

DRUG

80mg lurasidone

single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

DRUG

placebo

Sponsors & Collaborators

  • Xuhui Central Hospital, Shanghai

    collaborator OTHER

  • Sumitomo Pharma (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • ChaoYing Hu, MD · Xuhui Center Hospital, Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02174510 on ClinicalTrials.gov