NCT01082276

Rifampin Drug-Drug Interaction Study With Lurasidone HCl

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The effect of rifampin on the pharmacokinetics of lurasidone

Detailed description

by performing an open-label, 2-period, sequential study in healthy subjects. All subjects (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.

Conditions

• Male, Healthy Normal Subjects

Interventions

Type	Name	Description
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).

Timeline

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

Locations

1 site across 1 country: United States