JPRN-jRCT2080222396未知1 期
A phase I clinical pharmacology study of TAK-233 in healthy subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 24 人开始时间: 2014年2月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 性别
- Female
入选标准
- •1. Subjects who understand the contents of this clinical trial and who the investigator or sub-investigator consider able to comply with the procedures of the clinical trial
- •2. Subjects who can sign the informed consent form and can date the form without assistance before starting the procedures of the clinical trial
- •3. Healthy Japanese women
- •4. Subjects aged >= 20 and <= 40 years at the time of consent
- •5. Subjects with body weight >= 45 kg and BMI >=18.5 and <= 25.0 kg/m2 at the time of screening
- •6. Women of child bearing potential who agree to take specified contraceptive measures regularly from the time of consent until 4 weeks after the end of the last assessment in the fourth treatment period
排除标准
- •1. Subjects who received TAK-233 within 16 weeks before the start of initial administration
- •2. Subjects who have previously received TAK-233 during treatment or during participation in another clinical trial
- •3. Employees of the medical institution conducting this clinical trial and their family/dependents (e.g., husband or wife, parents, children, and siblings), or subjects who may be coerced to agree to participate in the clinical trial
- •4. Subjects with poorly controlled and clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (including chronic costiveness), urological (including dysuria), autoimmune, endocrine, or psychiatric diseases or other abnormalities which may affect the subject's participation in the clinical trial or results of the clinical trial
- •5. Subjects with hypersensitivity to TAK-233 related substances, or excipients of these products
- •6. Subjects whose urine tested positive for drug abuse at screening
- •7. Subjects with a history of drug abuse (defined as the use of illegal drugs) or alcohol dependence within 52 weeks before the screening assessments, or subjects who are not willing to stop alcohol intake or drug use during their participation in the clinical trial
- •8. Subjects who need to take prohibited concomitant medications, vitamins, or foods listed in listed in what?
- •9. Pregnant or lactating women, women expecting to be pregnant before giving consent, during this clinical trial, or within 4 weeks after the completion of this clinical trial, or women who are planning to donate their ova during this period
- •10. Subjects with currently active cardiovascular diseases, central nervous system diseases, hepatic diseases, hematopoietic diseases, renal failure, metabolic disorders, endocrine disorders, serious allergies, asthma, hypoxemia, hypertension, convulsion, allergic exanthema, or urological disorders (subjects with peptic ulcer, convulsive disorders, or arrhythmia also fall this category)
- •11. Subjects that have any of the following diseases/surgical interventions that may affect drug absorption: digestive system disorders (malabsorption, esophageal reflux, peptic ulcer, erosive oesophagitis, frequent heartburn (at least once a week), or surgical interventions (e.g., cholecystectomy), or subjects who have had prior history of any of these diseases/surgical interventions within the last 24 weeks
- •12. Subjects with a history of cancer (excluding subjects whose basal cell carcinoma has been in remission for at least 5 years)
- •13. Subjects that have tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, or syphilis serological reaction at screening
- •14. Subjects who took nicotine-containing products (e.g., cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 28 days before hospitalization
- •15. Subjects for whom blood collection from peripheral veins is difficult
- •16. Subjects who donated at least 200 mL of whole blood within 4 weeks before the start of the initial administration, or subjects who donated at least 400 mL of whole blood within 16 weeks before the start of the initial administration
- •17. Subjects who donated at least 400 mL (in total) of whole blood within 52 weeks before the start of the initial administration
- •18. Subjects who donated blood components within 2 weeks before the start of the initial administration
- •19. Subjects with clini
研究者
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