NCT00967772

The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers

A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Naftopidil	25mg/ 50 mg/ 75mg dosage tablets

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-10-01
• Completion: 2010-03-01
• First posted: 2009-08-28
• Last updated: 2014-10-01

Locations

1 site across 1 country: South Korea