NCT05259020Unknown1 期
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
研究概览
简要总结
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged over 19 years
- •Subjects who have over 50kg and BMI more than 18.5kg/m^2 and less than 29.9kg/m^2
- •Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
- •Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
- •Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
排除标准
- •• Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug
- •Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
- •Subject with symptoms of acute disease within 28days prior to study medication dosing
- •Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
- •Subject with a history of drug abuse or urinalysis positive
- •Subject with clinically significant active chronic disease
- •Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- •Genetic myopathic disorder or related family history
- •Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
- •Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- •Subject who cannot take standard meal in hospitalization
- •Present history of hypothyroidism or clinically significant assay
- •Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
- •Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
- •Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
- •Subjects who judged ineligible by the investigator
结局指标
主要结局
Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
时间窗: 0~72hr
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax
AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
时间窗: 0~72hr
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt
次要结局
- Cmax (Free Ezetimibe)(0~72hr)
- AUCt (Free Ezetimibe)(0~72hr)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered AloneHealthyNCT01662674LG Life Sciences27
已完成
1 期
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy ParticipantsHealthy VolunteersNCT06362642PMV Pharmaceuticals, Inc12
已完成
1 期
Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting ConditionHealthyNCT01606059Daewon Pharmaceutical Co., Ltd.30
已完成
1 期
Study to Compare Two Formulations of Lamotrigine in Healthy SubjectsMental DisordersNCT00410371GlaxoSmithKline96
已完成
1 期
To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105HealthyNCT06754943JW Pharmaceutical60