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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104948

Enrollment

106

Registered

2010-04-16

Start date

2010-05-31

Completion date

2011-10-31

Last updated

2012-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculatory Dysfunction

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.

Interventions

DRUGDA-8031

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026