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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01104948
First received: April 12, 2010
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Premature Ejaculatory Dysfunction
Drug: DA-8031
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 106
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-8031 Drug: DA-8031
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104948

Locations
Korea, Republic of
Clinical Research Institute, Seoul National University Hospital
Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01104948     History of Changes
Other Study ID Numbers: DA-8031
Study First Received: April 12, 2010
Last Updated: July 10, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on April 22, 2014