JPRN-jRCT1080223758已完成1 期
Comprehensive elucidation of novel active ingredient and novel activity mechanism of Maoto (TJ-27) by non-targeted metabolome-informatics.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
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 <= 45age old（—）
- 性别
- Male
入选标准
- •(1) Japanese
- •(2) Subject body mass index (BMI) is between 18.5 and 25.0 kg/m2
- •(3) Willing and able to provide written, signed informed consent
排除标准
- •(1) Subjects with a history of allergic reactions to drugs and foods.
- •(2) Subjects who have participated in another clinical trial within the past 16 weeks starting from the hospitalization date.
- •(3) Subjects who have had their blood drawn or donated >400mL of blood within the past 12 weeks starting from the hospitalization date.
- •(4) Subjects with history of significant hepatic, cardiovascular or hematological disease
- •(5) Subjects who can not quit drink or smoking from 2 days before the hospitalization date to the end of the hospitalization period.
- •(6) Subjects who can not interrupt drugs other than the test drug or who has taken it from 6 days before the hospitalization date to the end of the hospitalization period.
- •(7) Subjects who can not interrupt drinks, foods or supplements* containing crud drugs and foods below or ingest them from 2 days before hospitalization date to the end of hospitalization period.
- •Peach kernel, apricot kernel, cinnamon, ephedra herb, glycyrrhiza, foods containing glycyrrhiza [marked in raw material name], cinnamon, garlic, citrus fruits (grapefruit, oranges, oranges etc.), caffeine, alcohol, and seeds, pulp and leaves of plants Rosaceae Cerasus plants (apricot, plum, peach, asian plum, almond etc.) and eriobotrya (loquat).
- •(8) Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator.
- •(9) Subjects who are positive for HCV antibody, HBs antigen, and HIV antigen antibody.
- •(10) Subjects who are ingesting prohibited drugs amphetamine, methamphetamine, or ingested in the past.
- •(11) Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.
- •*In addition, supplements are any products that contain vitamins, minerals, herbs, amino acids and are intended to supplement normal diet.
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