NCT06725355进行中（未招募）1 期
A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of IN-R00002 and IN-G00002 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
- PK parameter
研究概览
简要总结
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
详细描述
A randomized, open-label, single-dose, crossover study
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 years at screening
- •Body weight > 60kg and Body mass index (BMI) in the range of 18.0 and 30.0 kg/㎡
- •Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings as a result of physical examination
- •Determined by the investigator to be eligible for study participation based on the results of screening tests (clinical laboratory tests, vital signs, physical examination, 12-lead ECG) conducted according to the IP characteristics
- •Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
排除标准
- •Subjects who have taken the drug which can induce or inhibit drug metabolism enzyme within 4 weeks prior to the 1st IP administration
- •Subjects who have participated in any other clinical study or bioequivalnece study within 6 months prior to the 1st IP administration
- •Subjects who have donated whole blood within 8 weeks prior to the 1st IP administration or have donated blood components or received transfusion within 2 weeks prior to the 1st IP administration
- •Pregnant(positive urine HCG) or breastfeeding women if female
- •Subject who have continued drink of alcohol within 1 month prior to the 1st IP administration (female: > 14 glasses per week, male > 21 glasses per week)
- •Subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines
- •Pregnant(positive urine HCG) or breastfeeding women if female
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects or spouses (or partners) are unable to use an effective method of contraception (e.g., correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), throughout the study
- •Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
研究组 & 干预措施
Sequence A
Experimental
R->T R: IN-R00002 T: IN-G00002
干预措施: IN-R00002 (Drug)
Sequence A
Experimental
R->T R: IN-R00002 T: IN-G00002
干预措施: IN-G00002 (Drug)
Sequence B
Experimental
T->R R: IN-R00002 T: IN-G00002
干预措施: IN-R00002 (Drug)
Sequence B
Experimental
T->R R: IN-R00002 T: IN-G00002
干预措施: IN-G00002 (Drug)
结局指标
主要结局
PK parameter
时间窗: Up to Day 2
Cmax of Edoxaban
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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