Administration study of Testosterone ester in healthy adult males

JRCT ID: jRCT1071220039

Registered date:10/08/2022

Basic Information

• Recruitment status: Complete

Health condition(s) or Problem(s) studied

Healthy adult subjects
Sample collection for evaluating analysis and sampling methods in antidoping

• Date of first enrollment: 05/09/2022
• Target sample size: 7
• Study type: Interventional
• Intervention(s): Blood and urine collection begins the day after subjects are hospitalized. After breakfast on the second day of hospitalization, 100 mg of the test drug (ENARMON DEPOT INTRAMUSCULAR INJECTION) is injected intramuscularly, and the biological samples are collected from the subject based on the test protocol.

Outcome(s)

• Primary Outcome: Effects of sample collection method: Sample collection time, type and amount of sample collected
• Secondary Outcome: Detectable period of unchanged and metabolites of test drugs: Sample collection time, type and amount of sample collected

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 35age old
• Gender: Male
• Include criteria: Japanease with BMI 18.5 or more and less than 25.0 at the time of prior examination. Person who is judged by Principal investigator or Sub-investigator that there is no problem with participation in the test.
• Exclude criteria: 1) A person who has caused allergic symptoms due to the study drug or the component of the study drug. 2) A person who is being treated for any disease or who may be treated during the test period. 3) A person suspected of having the following diseases or a person with a medical history. Androgen-dependent malignancies (eg prostate cancer), heart disease, renal disease, cancer. 4) Alcohol or drug dependents, depression or those with a medical history. 5) A person who used a medicinal or over-the-counter medication within 2 weeks of the scheduled administration of the study drug. 6) A person who has taken one or more supplements, foods containing Hyperethesia, grapefruit or their processed products within one week of the scheduled administration of the study drug. 7) A person who has received another investigational drug or investigational drug within 16 weeks of the scheduled study drug administration date, or an investigational drug or investigational drug containing an approved component within 12 weeks. 8) A person who received blood of 200 mL or more within 30 days of the scheduled administration of the study drug and 400 mL or more within 90 days and those who received blood donation of the component within 14 days of the scheduled administration. 9) A person who weighs less than 50 kg at the time of pre-examination. 10) A person who is confirmed negative by SARS-CoV-2 test or who are suspected of having a new coronavirus infection. 11) A person who has been judged by the Principal investigator or Sub-investigator to be inappropriate to participate in this test.

Related Information

• Primary Sponsor: Yomenura Takuma
• Secondary Sponsor: Okano Masato
• Source(s) of Monetary Support: Japan Anti-Doping Agency "JAPAN SPORT COUNCIL 2022 the Sports Promotion Fund"