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

Phase 1

Completed

• Conditions: Premature Ejaculatory Dysfunction
• Interventions: Drug: Placebo; Drug: DA-8031

• Registration Number: NCT01104948
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Study Start: 2010-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
DA-8031	DA-8031	-

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report

Trial Locations

Locations (1)

Clinical Research Institute, Seoul National University Hospital; 🇰🇷 Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of