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Administration study on preparation of testosterone undecanoate to healthy adult males

Administration study on preparation of testosterone undecanoate to healthy adult males

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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 27 healthy adults and 8 of them were administrered 80mg of testosterone undecanoate(two capsels of Andriol Testocaps 40mg). The testing process including collection of samples for all subjects was completed.

There were 3 adverse events (sore throat, nasal discharge, diarrhea) in 2 subjects, but all of them were mild and resolved without treatment, and judged to be unrelated to the study drug.

Administration study of testosterone undecanate (2 capsuls of Andriol Testocaps 40mg) was conducted with 8 healthy adult subjects. Urine samples were collected from each subject during scheduled time periods from 3 days before to 25 days after the administration. Blood samples were also collected from the subject's median brachial vein and phalangeal capillaries at a total of 11 points (-0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, and 7 hr after the administration, and at 9:00 AM on days 1 and 2 of administration).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.

Administration study of testosterone undecanate (2 capsuls of Andriol Testocaps 40mg) was conducted in which urine and blood samples were consequently collected from 8 healthy adult subjects in order to confirm the detection period of the unchanged drug and metabolites of testosterone undecanate, the effect of different blood collection methods on detection, and to evaluate our analytical methods.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1071210006

Yonemura Takuma

Souseikai Sumida Hospital

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

takuma-yonemura@lta-med.com

Kageyama Shinji

LSI Medience Corporation

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

+81-3-5994-2351

kageyama.shinji@mk.medience.co.jp

Complete

Feb. 10, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

Asian race
Person 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) Person who has caused allergic symptoms due to the study drug or the component of the study drug.
2) 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.
Tumor, cancer, liver disease, kidney disease, heart disease, diabetes, blood coagulation disorder, prostatic hyperplasia, sleep Apnea
4) Alcohol or drug dependents, depression or those with a medical history.
5)Those who are confirmed negative by SARS-CoV-2 test or who are suspected of having a new coronavirus infection.
6) A person who used a medicinal or over-the-counter medication within 2 weeks of the scheduled administration of the study drug.
7) Those who have taken one or more supplements, foods containing Hyperethesia, grapefruit or their processed products within one week of the scheduled administration of the study drug.
8) 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.
9) Patients 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.
10) Person who weighs less than 50 kg at the time of pre-examination.
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

The candidate subject is hospitalized and urine collection is started the next day. Orally the administration of 2 capsules of the study drug (testosterone undecanoate 40 mg capsules x 2 capsules) at breakfast on the second day of hospitalization. After that, biological samples (urine / blood) will be continuously collected from the subject based on the test protocol.

The evaluation on analysis method by examining the detectable period of the unchanged drug and the metabolite of the test drug

The confirmarion of the influence of the use of the test drug on biological marker variation

+81-922837701

Feb. 05, 2021

Spain