An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201603 and UIC201604 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- UIC201603 and co-administration of UIC201603 and UIC201604
- Conditions
- Healthy
- Sponsor
- Korea United Pharm. Inc.
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201603 and UIC201604 in healthy volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
- •Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
- •Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
- •Subjects able to read and understand a written informed consent, and willing to participate in the study.
- •For women, those who are confirmed not to be pregnant during a health examination
Exclusion Criteria
- •Clinically significant, liver, kidney, nervous system, respiratory system, blood/tumor, urinary system, Mental disorders, especially cardiovascular diseases (e.g. hypertension, angina pectoris, heart failure, myocardial infarction, etc.) Those who have or have a history of diseases related to the endocrine system (diabetes, hyperlipidemia, etc.)
- •Bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such predispositions (active peptic ulcer, hemorrhagic stroke within the past 6 months, surgery within the past 3 months, proliferative diabetic retinopathy, uncontrolled Patients with high blood pressure)
- •Patients with atrial or ventricular displacement, patients with atrial fibrillation or flutter, ventricular tachycardia, ventricular fibrillation, or Patients with multifocal ventricular ectopic beats and patients with prolonged QT interval
- •Gastrointestinal diseases that may affect the absorption of investigational drugs (Crohn's disease, ulcers) acute or chronic pancreatitis, etc.) or gastrointestinal surgery (however, simple appendectomy or Those with a history of hernia surgery (excluding hernia surgery)
- •Those with a history of hypersensitivity to Cilostazol or other antiplatelet agents,
- •Same series as rosuvastatin, atorvastatain, simvastatin, etc. (HMG-CoA Hypersensitivity reaction to the components of reductase inhibitor or clinically significant Those with a history of hypersensitivity reaction
- •Galactose intolerance, Lapp lactase deficiency lactose deficiency or glucose-galactose malabsorption People with genetic problems such as malabsorption
- •If PT and aPTT are outside the allowable range (diagnostic laboratory reference values are 11-15 sec, respectively, 22.4-40.4 sec)
- •Vital signs show systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, diastolic blood pressure ≥ 95 Either mmHg or \<60 mmHg, pulse rate ≥100 beats/min. Those who showed included figures
- •Those with high-density lipoprotein (HDL-cholesterol) less than 35 mg/dL
Arms & Interventions
Treatment A
UIC201603 and co-administration of UIC201603 and UIC201604
Intervention: UIC201603 and co-administration of UIC201603 and UIC201604
Treatment B
UIC201604 and co-administration of UIC201603 and UIC201604
Intervention: UIC201604 and co-administration of UIC201603 and UIC201604
Outcomes
Primary Outcomes
Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
Time Frame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Maximum concentration of drug in serum at steady state
Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
Time Frame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin
Time Frame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(Css,max) of Rosuvastatin
Time Frame: Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Maximum concentration of drug in serum at steady state