None listed
Conditions
Interventions
Drug : 1. Arm A
(1) Period 1: Cilostazol 100 mg, PO, Bid/day administration
(2) Period 2: UI02CST200CT (Cilostazol 200 mg), PO, 1 day administration
2. Arm B
(1) Period 1: UI02CST200CT (Cilost
Sponsors
Korea United Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) A healthy male subject ages 19 to 55 years (both inclusive) 2) A subject with body weight = 55 kg and in the range of ideal body weight (IBW) ± 20% (refer to Appendix7) 3) A subjects with findings within the range of clinical acceptability in medical history and physical examination 4) A subject with laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study) 5) A subject who is informed of the investigational nature of this study, and voluntarily agrees to participate in this study and signs informed consent
Exclusion criteria
Exclusion criteria: 1) A subject with drug hypersensitivity to cilostazol or other antiplatelet agents 2) A subject whose systolic blood pressure (SBP) = 100 mmHg or = 145 mmHg, diastolic blood pressure (DBP) = 50 mmHg or = 95 mmHg or pulse rate (PR) = 100 /min 3) A subject whose PT or aPTT test result was out of reference range (Reference range of PT and aPTT test were 11-15 sec, 22.4-40.4 sec, respectively) 4) A subject with clinical evidence or history of bleeding (hemophilia, Capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous bleeding, etc.) or bleeding tendency (active peptic ulcer, hemorrhagic stroke within 6 months, surgery within 3 months, proliferative diabetic retinopathy, uncontrolled hypertension, etc.) 5) A subject with clinical evidence or history of cardiovascular (congestive heart failure, coronary artery stenosis, etc.), respiratory, renal (severe renal failure, etc.), endocrine (diabetes or impaired glucose tolerance), hematologic (bleeding tendency), gastrointestinal, central nervous system, psychiatric, oncologic or hepatic (moderate or severe hepatic failure, etc.) disease 6) A subject with clinical evidence or history of atrial and ventricular displacement, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic beats or QT interval prolongation 7) A subject with history of gastrointestinal disease (Crohn’s disease, ulcer, etc.) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug 8) A subject with clinical evidence or history of peptic ulcer or gastrointestinal bleeding within 2 months prior to the scheduled 1st investigational product administration 9) A subject who consumes more than 21 units of alcohol per week (1unit=10g=12.5mL) or smokes more than 20 cigarettes per day, or unable to stop drinking or smoking throughout the study period 10) A subject who has participated in any other clinical trial either for investigational or marketed drugs within 3 months prior to the scheduled 1st investigational product administration 11) A subject who has donated whole blood within 2 months or any blood products within 1 month prior to the scheduled 1st investigational product administration 12) A subject who has taken any medication which can induce or inhibit drug metabolizing enzymes within 1 month prior to the scheduled 1st investigational product administration (e.g. barbiturate) 13) A subject who has taken any prescribed medication such as anticoagulants (warfarin, etc.), antiplatelet agents (aspirin, ticlopidine, etc.), thrombolytic agents (urokinase. alteplase, etc.) prostaglandin E1 (alprostadil, limaprost alfadex, etc.) or herbal compounds within 2 weeks prior to the scheduled 1st investigational product administration. In addition, a subject who has taken any over-the-counter drug within 1 week prior to the scheduled 1st investigational product administration. (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.) 14) A subject with psychiatric disorder or drug or alcohol abuse history 15) The investigator judges the subject is not eligible for the study after reviewing clinical laboratory results or other reasons 16) A subject who takes grape juice, grapefruit juice or grapefruit-containing products within 1 week prior to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast of Cilostazol, OPC-13015, OPC-13213;Cmax of Cilostazol, OPC-13015, OPC-13213 | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, tmax, t1/2ß, CL/F of Cilostazol, OPC-13015, OPC-13213 | — |
Countries
Korea, Republic of
Contacts
Public ContactJang Hong
Chungnam National University Hospital
Outcome results
None listed