Administration study on preparation of testosterone undecanoate to healthy adult males

JRCT ID: jRCT1071210006

Registered date:07/04/2021

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: 10/02/2021
• Target sample size: 8
• Countries of recruitment: Spain,Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: The evaluation on analysis method by examining the detectable period of the unchanged drug and the metabolite of the test drug
• Secondary Outcome: The confirmarion of the influence of the use of the test drug on biological marker variation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 35age old
• Gender: Male

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Yonemura Takuma