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

A Randomized, Open Label, Multiple Does, Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between Pleetal SR Cap. and Cilostan CR Tab. in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03524963

Enrollment

Registered

2018-05-15

Start date

2017-08-07

Completion date

2018-06-30

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Brief summary

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

Detailed description

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.

Interventions

DRUGCilostan CR Tab.

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

DRUGPletaal SR Cap.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Cmax	up to 24 hours after 1st dose	Maximal plasma concentration
AUC0-24	up to 24 hours after 1st dose	Area under the time-concentration curve
Cmax,ss	up to 72 hours after 5th dose	Maximal plasma concentration at steady-state
AUCtau	up to 24 hours after 5th dose	Area under the time-concentration curve

Secondary

Measure	Time frame	Description
AE	Up to 30 days after final dose	Adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026