JPRN-jRCTs031220120招募中未知
Determination of growth hormone and related peptides in serum and plasma using a novel analytical method developed as an anti-doping technology
Furihata Kenichi0 个研究点目标入组 6 人开始时间: 2022年6月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 6
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
- Male
入选标准
- •a)Healthy men at >=20 but <40 years of age when the consent was obtained.
- •b)Body mass index (BMI) at screening is between 18.5 and 25.0, and body weight is 50 kg or more.
- •c)Persons who were judged appropriate as subject s by the investigator (sub-investigator) based on medical history and physical exam and laboratory tests at screening.
- •All sub-research physicians must be affiliated with the P1 Clinic and approved to practice medicine in Japan.
- •d)Agree to the following during the administration period and for 10 days after the last dose of study drug
- •- Not to donate sperm.
- •In addition
- •- Do not engage in heterosexual sexual intercourse
- •- During intercourse with a woman of childbearing potential, in addition to the use of male condoms, the female partner must use a contraceptive method [oral hormonal contraceptive combination (estrogen-progestin combination), intrauterine hormone release system (IUS), intrauterine device without added hormones (IUD), bilateral tubal ligation]. consent to the use of bilateral tubal ligation].
- •e)Subjects who can understand and comply with the protocol and from whom the written consent based on his or her own free will can be obtained.
排除标准
- •a) Subjects with a history of hypersensitivity to growth hormone.
- •b) Subjects for whom growth hormone administration is contraindicated: diabetic patients, subjects with malignant tumors
- •c) Patients with hypotension (systolic blood press ure <90 mmHg) or hypertension (systolic blood pressure >160 mmHg) at the time of screening.
- •d) Those who have donated or lost more than 200 mL (1 unit) of blood within 4 weeks or 400 mL (2 units) within 3 months prior to administration of the study drug.
- •e) Subjects with significant neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, gastrointestinal (including gastrointestinal diseases that are judged to affect the absorption of the research drug), respiratory, or metabolic disease history/complications.
- •f) Subjects with clinically significant abnormalities that have been confirmed by the principal investigator or sub-investigator by medical examination or physical examination.
- •g) Subjects with clinically significant disease within 30 days prior to study drug administration.
- •h) Subjects who have consumed medicinal products or dietary supplements containing St. John'swort within 14 days prior to the start of the study, food or beverages (including foods containing grapefruit, oranges, or apples) and dietary supplements within 7 days prior to the start of the study, and who are unable to comply with the prohibition of consumption even during the study period.
- •i) Subjects who have smoked or ingested nicotine within 30 days prior to the administration of the study drug and are unable to comply with the prohibition of smoking during the study period.
- •j) Subjects who have consumed alcohol or caffeine-containing substances on the day before admission and are unable to comply with the prohibition of consumption by the day of discharge.
- •k) Those who have a positive breath alcohol test or urine drug test at the time of screening.
- •l) Patients who are unable to discontinue the use of any medication other than the study medication from 2 weeks prior to the administration of the study medication until the end of the study.
- •m) Those who are positive for Hepatitis B surface (HBs) antigen, hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen or antibody.
- •n) Persons who are judged by the principal investigator to have an underactive thyroid based on the results of thyroid function tests at screening.
- •o) Any other person who is judged to be inappropriate by the principal investigator or sub-investigator.
研究者
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