NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-194833

Registered date:01/07/2019

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

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studied-
Date of first enrollment17/7/2019
Target sample size19
Countries of recruitmentJapan
Study typeINTERVENTIONAL
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 Outcomeother Quantitative analysis of unaltered substance and metabolite concemtration of test drug in sample.
Secondary Outcomeother Variation of biological-pasort markers

Key inclusion & exclusion criteria

Age minimum20
Age maximum35
GenderMale
Include criteria1. 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 criteria1) 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

Contact

public contact
Name LSI Medoence Corporation Anti--Doping Laboratory
Address 3-30-1 Shimura Itabashi-Ku TOKYO, JAPAN
Telephone 81 3 5994 2181
E-mail kageyama.shinji@mk.medience.co.jp
Affiliation
scientific contact
Name LSI Medoence Corporation Anti--Doping Laboratory
Address 3-30-1 Shimura Itabashi-Ku TOKYO, JAPAN
Telephone 81 3 5994 2181
E-mail kageyama.shinji@mk.medience.co.jp
Affiliation