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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Naftopidil

Group Type EXPERIMENTAL

Naftopidil

Intervention Type DRUG

25mg/ 50 mg/ 75mg dosage tablets

Interventions

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Naftopidil

25mg/ 50 mg/ 75mg dosage tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes