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Midazolam Drug-Drug Interaction Study With Lurasidone HCl

NCT01082263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-08

No results posted yet for this study

Summary

A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

Conditions

  • Schizophrenia Patients

Interventions

DRUG

Lurasidone HCl

Day1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup)

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
2008-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

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 NCT01082263 on ClinicalTrials.gov