Administration test of dutasteride, bazedoxifene acetate and testosterone undecanoate preparation to healthy adult males

JAPIC ID: JapicCTI-194833

Registered date:01/07/2019

Basic Information

• Recruitment status: complete
• Health condition(s) or Problem(s) studied: -
• Date of first enrollment: 17/7/2019
• Target sample size: 19
• Countries of recruitment: Japan
• Study type: INTERVENTIONAL

Intervention(s)

Intervention name : Dutasteride
INN of the intervention : dutasteride
Dosage And administration of the intervention : Oral administration, one 0.5mg capsule, one dose after breakfast
Intervention name : Bazedoxifene Acetate
INN of the intervention : bazedoxifene
Dosage And administration of the intervention : Oral administration, one 20mg capsule, one dose after breakfast
Intervention name : Testosterone undecanoate
INN of the intervention : testosterone undecanoate
Dosage And administration of the intervention : Oral administration, two 40 mg capsules, one dose after breakfast
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcome

other
Quantitative analysis of unaltered substance and metabolite concemtration of test drug in sample.

Secondary Outcome

other
Variation of biological-pasort markers

Key inclusion & exclusion criteria

• Age minimum: 20
• Age maximum: 35
• Gender: Male

Include criteria

1. Person with BMI 18.5 or more and less than 25.0 at the time of prior examination.
2. Person who is judged by the 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.

Study drug-1: Liver dysfunction
Study drug-2: Thrombosis, antiphospholipid syndrome, kidney disease, liver disease
Study drug-3: 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) A person who used a medicinal or over-the-counter medication within 2 weeks of the scheduled administration of the study drug.
6) 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.
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) 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.
9) Person who weighs less than 50 kg at the time of pre-examination.
10) 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: LSI Medience Corporation
• Secondary Sponsor: -
• Source(s) of Monetary Support: Japan Anti-Doping Agency