An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52L Compared to Coadministration of C52R1H With C52R2 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUCt of AJU-C52
研究概览
简要总结
To evaluate the safety and pharmacokinetic characteristics of AJU-C52L in healthy adults
详细描述
This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1H with C52R2 and administration of AJU-C52L.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.
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 ≥ 19-year-old
- •Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- •Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
- •Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- •Those who agree to contraception during the participation of clinical trial
- •Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
排除标准
- •Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- •Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
- •Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
- •Those who has a history of gastrointestinal surgery
- •Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day
- •Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
- •Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
- •Women who are pregnant or who may be pregnant and breastfeed
研究组 & 干预措施
Sequence A
Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose
干预措施: C52R1H Tab. and C52R2 Tab. (Drug)
Sequence A
Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose
干预措施: AJU-C52L (Drug)
Sequence B
Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose
干预措施: C52R1H Tab. and C52R2 Tab. (Drug)
Sequence B
Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose
干预措施: AJU-C52L (Drug)
结局指标
主要结局
AUCt of AJU-C52
时间窗: Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Area under the concentration-time curve from time zero to time
Cmax of AJU-C52
时间窗: Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax: Maximum plasma concentration of the drug
次要结局
未报告次要终点