NCT02174523

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects. To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone in healthy Chinese subjects.

Detailed description

Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	40mg lurasidone
DRUG	placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-06-25
• Last updated: 2019-04-08
• Results posted: 2019-04-08

Locations

1 site across 1 country: China