Pharmacokinetics Study for Probucol

Korea Otsuka Pharmaceutical Co., Ltd.30 enrolled

Overview

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

probucolDRUG

group 3: 250 mg 1 tablet in the morning and evening

probucolDRUG

group 1: 250 mg

probucolDRUG

group 2: 250 mg 2 tablets at once in the morning

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria * Korean * Male * Age from 20 to 40 years at time of informed consent * BMI more than 19.0 and less than 25.0 * Subjects who meet the following criteria at the time of the screening * Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values Exclusion criteria * History or clinical evidence of significant medical history * Present or previous significant drug allergy to any prescription or OTC medication

Locations (1)

Seoul national univeristy

Seoul, South Korea

Outcomes

Primary Outcomes

Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.

Time frame: 1 month

Data from ClinicalTrials.gov

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