KCT0001845已完成未知
A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral Administration in Healthy Volunteers
ovotech Asia Korea0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the informed consent form
- •2) body weight: = 55kg(male), = 50kg(female)
- •3) BMI: 18.5 kg/m2 ? BMI < 25.0 kg/m2
- •? BMI(body mass index) = Body weight (kg)/[height (m)]2
- •4) in female subjects, the result of serum ß-hCG pregnancy test comes out negative at screening, urine ß-hCG test comes out negative before taking medication during the period set by this protocol have to be included one of the below conditions.
- •- postmenopausal(no natural menstruation at least 2 years)
- •- surgically sterile(hysterectomy or bilateral ovariotomy, tubal ligation or sterile condition by other ways)
- •- sterility of male partner before screening(proof the azoospermia after vasectomy), and this is the only parter of the subject.
- •- agree with using a proper and continuous method of contraception start on 14 days(at least) before the1st IND administraion and for 28 days(at least) after the last IND administraion
- •* proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap, do not use a hormones including contraceptive or oral contraceptive during the study.
- •5) if the male have a sex life with childbearing aged female, maintain proper contraception during the study and for 28 days after the last IND administraion, agree with do not donate the sperm(if the female partner is infertility, above contraceptions are not necessary)
- •6) Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial
排除标准
- •1) Hypersensitivity to a drug containing an ingredient of the investigational product(EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity
- •2) Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records
- •3) Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records
- •4) Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history
- •5) (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tu
- •6) Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption,
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