Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea

Bundang CHA Hospital30 enrolled

Overview

This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1). From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day). Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing. After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Artery Disease

Interventions

Cilostan CR Tab.DRUG

Cilostan CR Tab. 200mg once a day for 5 days

Pletaal SR Cap.DRUG

Pletaal SR Cap. 200mg once a day for 5 days

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects aged 20 - 45 years * BMI (body mass index) between 18.0 and 27.0 * Agreement with written informed consent Exclusion Criteria: * Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present) * Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin \> 1.5 x UNL) * Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab * Taking OTC (Over the counter) medicine including oriental medicine within 7 days * Clinically significant allergic disease * Subject with known for hypersensitivity reaction to Cilostazol * Previous whole blood donation within 60 days or component blood donation within 30 days * Previous participation of other trial within 90 days * Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)

Locations (1)

CHA Bundang Medical Center

Seongnam, South Korea

Outcomes

Primary Outcomes

Cmax

Maximal plasma concentration

Time frame: up to 24 hours after 1st dose

AUC0-24

Area under the time-concentration curve

Time frame: up to 24 hours after 1st dose

Cmax,ss

Maximal plasma concentration at steady-state

Time frame: up to 72 hours after 5th dose

AUCtau

Area under the time-concentration curve

Time frame: up to 24 hours after 5th dose

Secondary Outcomes

Adverse events

Time frame: Up to 30 days after final dose

Data from ClinicalTrials.gov

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