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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Erectile Dysfunction

Treatments: Dietary Supplement: Alcohol; Drug: Udenafil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01241032

2006-0086

Details and patient eligibility

About

This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers

Enrollment: 24 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Udenafil

Experimental group

Description:

Udenafil 200mg

Treatment:

Drug: Udenafil

Udenafil + Alcohol

Active Comparator group

Description:

Udenafil 200mg + Alcohol

Treatment:

Drug: Udenafil

Dietary Supplement: Alcohol