- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01241032
Phase I Study to Investigate the Alcohol Interaction of DA8159 (DA8159_DIA_I)
November 15, 2010 updated by: Asan Medical Center
A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Udenafil
Udenafil 200mg
|
200mg Single Oral Dose of
|
Active Comparator: Udenafil + Alcohol
Udenafil 200mg + Alcohol
|
200mg Single Oral Dose of
Alcohol 39g / 240ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (AUC and Cmax)
Time Frame: 48 Hours
|
48 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
November 15, 2010
First Submitted That Met QC Criteria
November 15, 2010
First Posted (Estimate)
November 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 16, 2010
Last Update Submitted That Met QC Criteria
November 15, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-0086
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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