Healthy
Conditions
Keywords
PK assessment for healthy male volunteer, Healthy male subjects aged 20 to 40 years
Brief summary
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.
Detailed description
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.
Interventions
DRUGprobucol
group 3: 250 mg 1 tablet in the morning and evening
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc. | 1 month |
Countries
South Korea
Outcome results
None listed