drugset / Trial / NCT00967772

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

NCT00967772

Phase 1 Completed 16 enrolled Dong-A ST Co., Ltd.
Parallel-groupSingle-blindBasic science

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).

Timeline

Start
2009-09
Primary completion
2009-10
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Naftopidil Small molecule 25 mg Oral
Subject Naftopidil Small molecule 50 mg Oral
Subject Naftopidil Small molecule 75 mg Oral

Indications

No indication recorded.