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Lithium Drug-Drug Interaction Study With Lurasidone HCl

NCT01074073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.

Conditions

Interventions

DRUG

Lurasidone HCl

lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD). Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID). On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Marina Bussel, MD · CCT/Parexel

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT01074073 on ClinicalTrials.gov