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

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of DA-8031 After Oral Administration in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculatory Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: DA-8031

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chongno-Gu, Yon-Gon Dong 28
    • Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of, 110-744
      • Clinical Research Institute, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: DA-8031	Drug: DA-8031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: DA-8031