JPRN-jRCT2080222761未知1 期
A Randomized, Open-label, Crossover Phase 1 Study to Evaluate the Bioequivalence Following a Single Oral Dose Administration of SYR-472 25mg and 50mg Tablets in Healthy Adult Male Subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 24 人开始时间: 2015年2月19日最近更新:
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 <= 35age old（—）
- 性别
- Male
入选标准
- •1.Participants who understand the outline of the clinical study and are capable of complying with their responsibilities as participants, as judged by the investigator or subinvestigator.
- •2.Participants who can sign and date the informed consent form before the initiation of the study procedure
- •3.Healthy Japanese adult males.
- •4.Participants who are 20 to 35 years of age at the time of informed consent.
- •5.Participants who weigh 50.0 kg or more with a body mass index (BMI) of 18.5 to less than 25.0 kg/m2 in the screening period.
排除标准
- •1.Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1.
- •2.Participants who have received SYR-472 in the past.
- •3.Employees of the study site, their family members, those who are in a dependency relationship with employees of the study site involved in the conduct of the study (e.g., spouse, parents, children, brothers and sisters), and those who might be coerced to consent to participate in the study.
- •4.Participants who have poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lung, liver, kidneys, metabolism, gastrointestinal system, urinary system, or endocrinological system, which possibly may affect study participation or study results.
- •5.Participants who have a positive urine drug test in the screening period.
- •6.Participants who need to use drugs or foods listed in the table of prohibited concomitant drugs and foods.
- •7.Participants who have a history of hypersensitivity or allergy to drugs (including SYR-472 and its ingredients).
- •8.Participants who currently have or recently had (within the past 6 months) gastrointestinal disease that may affect drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week] heartburn, surgical intervention [e.g., cholecystectomy]).
- •9.Participants with a past history of cancer.
- •10.Participants who are postive for any of the following during the screening period: hepatitis B virus surface antigen (HBsAg), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological test for syphilis.
- •11.Participants with difficulty having blood collected from a peripheral vein.
- •12.Participants who donated 200 mL or more of whole blood within the 4 weeks (28 days) or 400 mL or more of whole blood within the 12 weeks (84 days) before starting the study drug administration in stage 1.
- •13.Participants who donated a total of 800 mL or more of whole blood within the 52 weeks (364 days) before starting the study drug administration in stage 1.
- •14.Participants who donated blood components within the 2 weeks (14 days) before starting the study drug administration in stage 1.
- •15.Participants who show clinically significant abnormalities in electrocardiogram (ECG) during the screening period or on Day 1 (before the study drug administration).
- •16.Participants who have laboratory test abnormalities suggestive of a clinically significant primary disease or who have abnormal values in any of the following parameters: ALT or AST exceeding 1.5 times the upper limit of the normal range.
- •17.Participants who are unlikely to comply with the study protocol or are ineligible for the study for any other reason, as judged by the investigator or subinvestigator.
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