DA8159_DIA_I: Phase I Study to Investigate the Alcohol Interaction of DA8159

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01241032

Collaborator

Dong-A Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arms

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Erectile Dysfunction	Drug: Udenafil Dietary Supplement: Alcohol	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Udenafil Udenafil 200mg	Drug: Udenafil 200mg Single Oral Dose of
Active Comparator: Udenafil + Alcohol Udenafil 200mg + Alcohol	Drug: Udenafil 200mg Single Oral Dose of Dietary Supplement: Alcohol Alcohol 39g / 240ml

Arm

Intervention/Treatment

Experimental: Udenafil

Udenafil 200mg

Drug: Udenafil

200mg Single Oral Dose of

Active Comparator: Udenafil + Alcohol

Udenafil 200mg + Alcohol

Drug: Udenafil

200mg Single Oral Dose of

Dietary Supplement: Alcohol

Alcohol 39g / 240ml

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (AUC and Cmax) [48 Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.