JPRN-jRCT2031200434已完成1 期
Additional pharmacokinetic study of GCP-002 (EP-HMRG) in healthy adult males.
Maruyama Tatsuya0 个研究点目标入组 6 人开始时间: 2021年3月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
From the results of this study, it was confirmed that the major metabolite of GCP-002 (EP-HMRG) in humans is HMRG-glucuronide conjugate, which reaches Cmax 1-2h after administration and disappears from the bloodstream by 168h after administration.The results of this study also confirmed the safety of GCP-002 (EP-HMRG) in 6 healthy adult males.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 性别
- Male
入选标准
- •1.Subjects who provide a signed document of informed consent for participation in the study
- •2.Subjects who are male
- •3.Subjects whose consent date of this trial is between 20 and 40 years old
- •4.Body Mass Index (BMI):18.0 kg/m2 to less than 26.0 kg/m2
- •5.Subjects who can be hospitalized by the date before treatment to the fourth days of treatment
- •6.Subjects who have AST, ALT, gamma-GTP, BUN, and Cre within the facility standard values for clinical test items derived from liver and kidney in the screening test
- •7.Subjects who can be contraceptive using condoms and other contraceptive methods for 3 months after administration of investigational products
排除标准
- •1. Subjects current medical history or past medical history (drug addiction, alcohol addiction, drug allergy, allergic disease, heart/liver/kidney/lung/blood disease) judged to be inappropriate for participation in in this study by the Principal investigator or Sub investigator
- •2.Subjects positive for urinary drug concentration tests (phencyclidines, benzodiazepines, cocaine narcotics, stimulants, cannabis, morphine narcotics, barbiturates, tricyclic antidepressants, etc.)
- •3. Subjects positive for hepatitis B, hepatitis C, HIV test, and syphilis test
- •4. Subjects regular use excessive alcohol or cigarettes (who can quit drinking or quit smoking during hospitalization)
- •5. Subjects who received other investigational products within 3 months before the screening examination
- •6. Subjects to used drugs (including prescription drugs, over-the-counter drugs, herbal medicines, vitamins, dietary supplements and beverages) within 1 week before study drug administration, or plan to use drugs other than the investigational products by the end of the study
- •7. Subjects who blood donated 400 mL within 3 months or 200 mL within 1 month before the screening test
- •8. Subjects who the principal Investigator or subinvestigator considers not suitable for this trial.
研究者
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