NCT06568133已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Those whose serum potassium concentration is less than 3.4 mEq/L or more than 5.5 mEq/L
- •Have a history of muscle disease or a personal or family history of hereditary muscle abnormalities ruler
- •Patients with biliary obstructive disease
- •Unexplained persistent elevation of serum transaminases or three times the upper limit of normal Patients with active liver disease including excess serum transaminase elevations
- •Patients with severe renal impairment (creatinine clearance calculated by the Cockcroft-Gault equation is 30 Those with less than mL/min)
- •Those with a history of drug abuse or a positive drug abuse test
- •Induction of drug metabolizing enzymes such as barbiturates within 1 month before the first administration date and Those who take suppressive drugs or drink excessively
- •Those who have taken any prescription medicine or herbal medicine within 2 weeks before the first medication date, or any over-the-counter medicine (OTC medicine) or vitamin supplement within 10 days (except, Depending on the investigator's judgment, you may participate in the clinical trial if other conditions are reasonable. has exist)
- •Participating in another clinical trial or bioequivalence test within 3 months before the first administration date Person who administered clinical trial drug
- •Donate whole blood within 2 months or component blood within 1 month before the first dose. or received a blood transfusion within 1 month before the first dose
- •For women, pregnant/nursing or currently using a medically acceptable form of contraception. Those who are not using contraception or are unable to maintain contraception during the clinical trial period
- •Clinical test performance The investigator may not conduct a clinical trial due to test results or other reasons. Those judged unsuitable for participation
研究组 & 干预措施
Treatment A
Experimental
UIC201603 and co-administration of UIC201603 and UIC201604
干预措施: UIC201603 and co-administration of UIC201603 and UIC201604 (Drug)
Treatment B
Experimental
UIC201604 and co-administration of UIC201603 and UIC201604
干预措施: UIC201604 and co-administration of UIC201603 and UIC201604 (Drug)
结局指标
主要结局
Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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