Pharmacokinetics Study for Probucol

Otsuka

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: probucol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000467

009-KOB-0801i

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

2

Active Comparator group

Description:

Group 2(probucol 500mg BID)

Treatment:

Drug: probucol

Drug: probucol

Drug: probucol

1

Active Comparator group

Description:

Group 1(Probucol 250mg)

Treatment:

Drug: probucol

Drug: probucol

Drug: probucol

3

Active Comparator group

Description:

Group 3(Probucol 500mg once daily)

Treatment:

Drug: probucol

Drug: probucol

Drug: probucol