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

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ClinicalTrials.gov Identifier: NCT01104948
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Premature Ejaculatory Dysfunction Drug: DA-8031 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: DA-8031 Drug: DA-8031
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01104948     History of Changes
Other Study ID Numbers: DA-8031
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012