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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Cilostan CR Tab.
* Drug: Pletaal SR Cap.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2 | Drug: Cilostan CR Tab.<br>* Cilostan CR Tab. 200mg once a day for 5 days<br>Drug: Pletaal SR Cap.<br>* Pletaal SR Cap. 200mg once a day for 5 days<br>|
| Experimental: Sequence B<br>Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2 | Drug: Cilostan CR Tab.<br>* Cilostan CR Tab. 200mg once a day for 5 days<br>Drug: Pletaal SR Cap.<br>* Pletaal SR Cap. 200mg once a day for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | Adverse events | Up to 30 days after final dose |