Drug-drug Interaction Study Between UIC201603, and UIC201604
- Conditions
- Healthy
- Registration Number
- NCT06568133
- Lead Sponsor
- Korea United Pharm. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria:<br><br> 1. Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body<br> Weight;<br><br> 2. Subjects without congenital disease, chronic disease, symptom or any clinical<br> significance of a physical examination and questionnaires;<br><br> 3. Subjects judged as healthy by laboratory tests including blood haematology,<br> biochemistry, urinalysis and serologic tests;<br><br> 4. Subjects able to read and understand a written informed consent, and willing to<br> participate in the study.<br><br> 5. For women, those who are confirmed not to be pregnant during a health examination<br><br>Exclusion Criteria:<br><br> 1. Clinically significant, liver, kidney, nervous system, respiratory system,<br> blood/tumor, urinary system, Mental disorders, especially cardiovascular diseases<br> (e.g. hypertension, angina pectoris, heart failure, myocardial infarction, etc.)<br> Those who have or have a history of diseases related to the endocrine system<br> (diabetes, hyperlipidemia, etc.)<br><br> 2. Bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper digestive<br> tract hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)<br> or such predispositions (active peptic ulcer, hemorrhagic stroke within the past 6<br> months, surgery within the past 3 months, proliferative diabetic retinopathy,<br> uncontrolled Patients with high blood pressure)<br><br> 3. Patients with atrial or ventricular displacement, patients with atrial fibrillation<br> or flutter, ventricular tachycardia, ventricular fibrillation, or Patients with<br> multifocal ventricular ectopic beats and patients with prolonged QT interval<br><br> 4. Gastrointestinal diseases that may affect the absorption of investigational drugs<br> (Crohn's disease, ulcers) acute or chronic pancreatitis, etc.) or gastrointestinal<br> surgery (however, simple appendectomy or Those with a history of hernia surgery<br> (excluding hernia surgery)<br><br> 5. Those with a history of hypersensitivity to Cilostazol or other antiplatelet agents,<br><br> 6. Same series as rosuvastatin, atorvastatain, simvastatin, etc. (HMG-CoA<br> Hypersensitivity reaction to the components of reductase inhibitor or clinically<br> significant Those with a history of hypersensitivity reaction<br><br> 7. Galactose intolerance, Lapp lactase deficiency lactose deficiency or<br> glucose-galactose malabsorption People with genetic problems such as malabsorption<br><br> 8. If PT and aPTT are outside the allowable range (diagnostic laboratory reference<br> values are 11-15 sec, respectively, 22.4-40.4 sec)<br><br> 9. Vital signs show systolic blood pressure = 140 mmHg or < 90 mmHg, diastolic blood<br> pressure = 95 Either mmHg or <60 mmHg, pulse rate =100 beats/min. Those who showed<br> included figures<br><br> 10. Those with high-density lipoprotein (HDL-cholesterol) less than 35 mg/dL<br><br> 11. Those whose serum potassium concentration is less than 3.4 mEq/L or more than 5.5<br> mEq/L<br><br> 12. Have a history of muscle disease or a personal or family history of hereditary<br> muscle abnormalities ruler<br><br> 13. Patients with biliary obstructive disease<br><br> 14. Unexplained persistent elevation of serum transaminases or three times the upper<br> limit of normal Patients with active liver disease including excess serum<br> transaminase elevations<br><br> 15. Patients with severe renal impairment (creatinine clearance calculated by the<br> Cockcroft-Gault equation is 30 Those with less than mL/min)<br><br> 16. Those with a history of drug abuse or a positive drug abuse test<br><br> 17. Induction of drug metabolizing enzymes such as barbiturates within 1 month before<br> the first administration date and Those who take suppressive drugs or drink<br> excessively<br><br> 18. Those who have taken any prescription medicine or herbal medicine within 2 weeks<br> before the first medication date, or any over-the-counter medicine (OTC medicine) or<br> vitamin supplement within 10 days (except, Depending on the investigator's judgment,<br> you may participate in the clinical trial if other conditions are reasonable. has<br> exist)<br><br> 19. Participating in another clinical trial or bioequivalence test within 3 months<br> before the first administration date Person who administered clinical trial drug<br><br> 20. Donate whole blood within 2 months or component blood within 1 month before the<br> first dose. or received a blood transfusion within 1 month before the first dose<br><br> 21. For women, pregnant/nursing or currently using a medically acceptable form of<br> contraception. Those who are not using contraception or are unable to maintain<br> contraception during the clinical trial period<br><br> 22. Clinical test performance The investigator may not conduct a clinical trial due to<br> test results or other reasons. Those judged unsuitable for participation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma pharmacokinetics(AUCss,t) of Cilostazol and Active metabolites(OPC-13015, OPC-13213);Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213);Plasma pharmacokinetics(AUCss,t) of Rosuvastatin;Plasma pharmacokinetics(Css,max) of Rosuvastatin
- Secondary Outcome Measures
Name Time Method