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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2 |
|
| Sequence B | Experimental | Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostan CR Tab. | Drug | Cilostan CR Tab. 200mg once a day for 5 days |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Adverse events | Up to 30 days after final dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam | 13496 | South Korea |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Pletaal SR Cap. | Drug | Pletaal SR Cap. 200mg once a day for 5 days |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |