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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Premature Ejaculatory Dysfunction

Treatments: Drug: Placebo; Drug: DA-8031

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104948

DA-8031

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

DA-8031

Experimental group

Treatment:

Drug: DA-8031

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo