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A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects

NCT ID: NCT01104948

Last Updated: 2012-07-11

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

Brief Summary

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This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.

Detailed Description

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Conditions

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Premature Ejaculatory Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DA-8031

Group Type EXPERIMENTAL

DA-8031

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DA-8031

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20-45 years healthy male subjects
* Body weight :60-90kg, BMI between 18.5-25

Exclusion Criteria

* show SBP(Systolic Blood Pressure) =\<100mmHg or \>=140mmHg, or DBP(Diastolic Blood Pressure)=\<60mmHg or \>=90mmHg, or tachycardia (PR(Pulse Rate)\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Institute, Seoul National University Hospital

Seoul, Chongno-Gu, Yon-Gon Dong 28, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA-8031

Identifier Type: -

Identifier Source: org_study_id