臨床研究等提出・公開システム

Administration study of Testosterone ester in healthy adult males

Administration study of Testosterone ester in healthy adult males

7

In this study, subjects were selected from healthy adult males aged 20-35 years with a BMI of 18.5-25.0.

Consent forms were obtained from 24 healthy adults and 7 of them were administrered 100mg of testosterone enanthate. The testing process including collection of samples for all subjects was completed.

No adverse event was observed in the administration study.

ENARMON DEPOT INTRAMUSCULAR INJECTION (100 mg of testosterone enanthate) administration study was conducted with 8 healthy adult male subjects. All of their spot urine were collected from the day before administration to 48 hours (discharge) and thereafter, urine samples were collected from the subjects at 96, 144 and 216 hours after the administration. Blood samles were also collected from the subject's brachial median mesothelial vein, fingertip capillary and brachial capillary at a total of 22 predetermined times according to the study plan. The biological samples were consequently obtained for our research to evaluate the detection period of the unchanged drug and metabolites, the effect of different blood collection methods on detection, and the evaluation of analytical methods.

ENARMON DEPOT INTRAMUSCULAR INJECTION (100 mg of testosterone enanthate) administration study was couductied in which urine and blood samples were consequently collected from 8 healthy adult male subjects in order to conform detectable period for the unchanged form and metabolites of testosterone enanthate, the effect of differences among blood collection methods on the detection of doping in sports, and also to evaluate our analytical method.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1071220039

Yomenura Takuma

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo 130-0004, Japan

takuma-yonemura@lta-med.com

Sato Mitsuhiko

LSI Medience Corporation

1-15-10 Shimura Itabashi-ku, Tokyo, Japan

+81-3-5994-2351

satou.mitsuhiko@ma.medience.co.jp

Complete

Aug. 10, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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.

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.

Male

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

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.

Effects of sample collection method: Sample collection time, type and amount of sample collected

Detectable period of unchanged and metabolites of test drugs: Sample collection time, type and amount of sample collected

+81-92-283-7701

June. 20, 2022

none