Phase I Study to Investigate the Alcohol Interaction of DA8159 (DA8159_DIA_I)

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01241032
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 15, 2010
November 15, 2010
June 2006
February 2007   (final data collection date for primary outcome measure)
Pharmacokinetics (AUC and Cmax) [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase I Study to Investigate the Alcohol Interaction of DA8159
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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Healthy Volunteers
  • Erectile Dysfunction
  • Drug: Udenafil
    200mg Single Oral Dose of
  • Dietary Supplement: Alcohol
    Alcohol 39g / 240ml
  • Experimental: Udenafil
    Udenafil 200mg
    Intervention: Drug: Udenafil
  • Active Comparator: Udenafil + Alcohol
    Udenafil 200mg + Alcohol
    Interventions:
    • Drug: Udenafil
    • Dietary Supplement: Alcohol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
February 2007   (final data collection date for primary outcome measure)

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.
Male
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01241032
2006-0086
No
Clinical Development Team1, Dong-A Pharmaceutical Co., Ltd.
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Asan Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP