JPRN-jRCT2031200085已完成1 期
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: 2020年8月17日最近更新:
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
The safety of GCP-002 (EP-HMRG) was confirmed in 6 healthy adult males. On the other hand, in the pharmacokinetic evaluation, GCP-002 (EP-HMRG) was not detected in the blood, but it was confirmed that HMRG was present in the blood even 24 hours after administration, and further investigation of the excretion process is necessary. Was suggested.
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 second day 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 hepatitis B, hepatitis C, HIV test, and syphilis test
- •3. Subjects regular use excessive alcohol or cigarettes (who can quit drinking or quit smoking during hospitalization)
- •4. Subjects who received other investigational products within 3 months before the screening examination
- •5. 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
- •6. Subjects who blood donated 400 mL within 3 months or 200 mL within 1 month before the screening test
- •7. Subjects who the principal Investigator or subinvestigator considers not suitable for this trial.
研究者
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