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

NCT00967772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-10-01

No results posted yet for this study

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

DRUG

Naftopidil

25mg/ 50 mg/ 75mg dosage tablets

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D.,Ph.D. · Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital

Study Design

Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967772 on ClinicalTrials.gov