Phase I Study to Investigate the Alcohol Interaction of DA8159 (DA8159_DIA_I)
Primary Purpose
Healthy Volunteers, Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
Alcohol
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy Volunteers focused on measuring DA-8159, Udenafil, Alcohol
Eligibility Criteria
Inclusion Criteria:
- Adult males aged 19 to 55 years at screening.
- Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion Criteria:
- Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Udenafil
Udenafil + Alcohol
Arm Description
Udenafil 200mg
Udenafil 200mg + Alcohol
Outcomes
Primary Outcome Measures
Pharmacokinetics (AUC and Cmax)
Secondary Outcome Measures
Full Information
NCT ID
NCT01241032
First Posted
November 15, 2010
Last Updated
November 15, 2010
Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01241032
Brief Title
Phase I Study to Investigate the Alcohol Interaction of DA8159
Acronym
DA8159_DIA_I
Official Title
A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Erectile Dysfunction
Keywords
DA-8159, Udenafil, Alcohol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Udenafil
Arm Type
Experimental
Arm Description
Udenafil 200mg
Arm Title
Udenafil + Alcohol
Arm Type
Active Comparator
Arm Description
Udenafil 200mg + Alcohol
Intervention Type
Drug
Intervention Name(s)
Udenafil
Intervention Description
200mg Single Oral Dose of
Intervention Type
Dietary Supplement
Intervention Name(s)
Alcohol
Intervention Description
Alcohol 39g / 240ml
Primary Outcome Measure Information:
Title
Pharmacokinetics (AUC and Cmax)
Time Frame
48 Hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult males aged 19 to 55 years at screening.
Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion Criteria:
Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
Subjects with hypotension or hypertension.
Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyun-Seop Bae, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://crc.amc.seoul.kr
Description
Clinical Research Center, Asan Medical Center
Learn more about this trial
Phase I Study to Investigate the Alcohol Interaction of DA8159
We'll reach out to this number within 24 hrs