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

September 30, 2014 updated by: Dong-A ST Co., Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Clinical Trial center, Clinical Research institute, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males subjects, 20-45 years inclusive
  • Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive
  • Written informed consent given

Exclusion Criteria:

  • Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil
  • History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology
  • Have a history of drug abuse, or show positive for drug abuse at urine screening
  • Have participated in another clinical study within 2 months prior to entering inth the study
  • Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Naftopidil
Drug: Naftopidil
25mg/ 50 mg/ 75mg dosage tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of naftopidil
Time Frame: Dec. 2009 (anticipated)
Dec. 2009 (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (ESTIMATE)

August 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLV100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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