NCT07655960已完成1 期
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over to Evaluate the Safety and Pharmacokinetics of AJU-C716 Compared to C716R in Healthy Adult Volunteers
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
研究概览
简要总结
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 19 and 55 years of age at the time of screening.
- •Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.
- •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 the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
- •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 use highly effective methods of contraception(excluding hormonal methods) to prevent pregnancy, either for themselves or their spouse/partner, from the first administration of the investigational medicinal product until one week after the last administration, and who agree not to donate sperm or eggs during this period.
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
- •Individuals with severe hepatic impairment, biliary obstruction, or cholestasis
- •Those taking cyclosporin
- •Those with myopathy
- •Those with a history of hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5, Sunset Yellow FCF).
- •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 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)
Sequence B
Experimental
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
干预措施: Test Drug (Drug)
Sequence B
Experimental
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
干预措施: Reference Drug (Drug)
研究者
研究点 (1)
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