Phase I Study to Investigate the Alcohol Interaction of SK3530

SK Chemicals Co., Ltd.18 enrolled

Overview

This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

SK3530DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ages 20 to 50 * body weight of IBM ± 20% Exclusion Criteria: * cardiovascular disease * color-blindness or weakness * no availability to intake 0.5 g/Kg alcohol * abnormal supine blood preesure

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

PK parameters - AUC, Cmax

Time frame: 24hr after administration

Secondary Outcomes

Safety (Vital signs, Adverse events)

Time frame: until post-study visit

Data from ClinicalTrials.gov

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