NCT01082263

Midazolam Drug-Drug Interaction Study With Lurasidone HCl

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

lurasidone 120 mg, midazolam 5 mg To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg. To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Conditions

• Schizophrenia Patients

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2010-03-08
• Last updated: 2011-09-08

Locations

1 site across 1 country: United States