NCT06933459进行中（未招募）1 期
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C714 Compared to C714R in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUCt of AJU-C714
研究概览
简要总结
To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult over 19 years of age and under 65 years of age.
- •Weight ≥ 50 kg (man) or 45 kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m
- •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 voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial.
- •Those who agree to contraception during the participation of clinical trial.
排除标准
- •Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
- •Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
- •Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
- •Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
- •Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
- •Those who has under
- •Those who are hypersensitive to component of the Investigational product and have the medical history
- •Those with active liver disease or persistent elevation of aminotransferase levels of unknown
- •Those with myopathy
- •Those taking cyclosporin
- •Those with renal impairment with severe renal failure
- •Those with Hypothyroidism
- •Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Those who has a history of mental illness.
- •Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
- •Women who are pregnant or who may be pregnant and breastfeed.
研究组 & 干预措施
Sequence B
Experimental
Period 1: Test Drug, single dose Period 2: Reference Drug, single dose
干预措施: Reference Drug (Drug)
Sequence B
Experimental
Period 1: Test Drug, single dose Period 2: Reference Drug, single dose
干预措施: Test Drug (Drug)
Sequence A
Experimental
Period 1: Reference Drug, single dose Period 2: Test Drug, single dose
干预措施: Test Drug (Drug)
Sequence A
Experimental
Period 1: Reference Drug, single dose Period 2: Test Drug, single dose
干预措施: Reference Drug (Drug)
结局指标
主要结局
AUCt of AJU-C714
时间窗: Pre-dose(0 hours), 3, 5, 10, 15, 20, 30, 40, 50 minutes, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours
Cmax of AJU-C714
时间窗: Pre-dose(0 hours), 3, 5, 10, 15, 20, 30, 40, 50 minutes, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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