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Rifampin Drug-Drug Interaction Study With Lurasidone HCl

NCT01082276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-09-08

No results posted yet for this study

Summary

The effect of rifampin on the pharmacokinetics of lurasidone

Conditions

  • Male, Healthy Normal Subjects

Interventions

DRUG

Lurasidone HCl

40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater, MD · PAREXEL Clinical Pharmacology Research Unit at Baltimore, MD

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

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

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 NCT01082276 on ClinicalTrials.gov