Administration study of percutaneous absorption type testosterone to healthy adult males

Not Applicable

• Conditions: /A

• Registration Number: JPRN-jRCT1080223675
• Lead Sponsor: SI Medience Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

1. BMI: 18.5 - 25.0
2. Nationality: Japanese

Exclusion Criteria

1. A person who had shown symptoms of allergy caused by this test drug or its composition.
2. A person who is suffering from androgen-dependent tumors and who is suspected to have the disease.
3. A person who had an enlarged prostate, a person whose PSA level is higher than 2.0ng/mL and who has a visceral disease or a history of the disease.
4. A person who is suffering from Sleep apnea syndrome.
5. A history of alcohol or drug addiction,
6. Under the medical treatment or it may treat of a certain disease,
7. Ethical or OTC pharmaceuticals administered within two weeks before scheduled administration of the study drug, Supplement, grapefruit or its products, or foods coating Western St. John's consumed within one week before scheduled administration of the study drug.
8. Not less than 200mL of blood is collected within 30 days or not less than 400mL of blood is collected within 90 days before scheduled administration of the study drug.
9. Weight: less than 50kg (at the time of a prior inspection),
10. A person shall not have a schedule of consultation of another hospital until this administration study.
11. A person judged unfit of this study by responsible doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified