Healthy adult subjects Sample collection for evaluating analysis and sampling methods in antidoping
Conditions
Interventions
Any one of the study drug ZAGALLO Capsules 0.5mg, Viviant Tablets 20mg and Andriol Testocaps 40mg is administered orally as a single dose to the subject after breakfast, and urine and blood samples a
Sponsors
Anti-Doping Laboratory, LSI Medience Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria: 1) A person who has caused allergic symptoms due to the study drug or the component of the study drug. 2) A 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 ethical pharmaceuticals or over-the-counter drugs within 2 weeks of the scheduled administration of the study drug. 6) A person who has taken one or more supplements, foods containing Hyperesthesia, 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) A person 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) A 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the detectable period of unchanged test drug and metabolites to evaluate the analytical method: time of sampling, type and volume of sample collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of the detectable period of unchanged test drug and metabolites to evaluate the analytical method: time of sampling, type and volume of sample collected. | — |
Countries
Japan
Contacts
Public ContactMitsuhiko Sato
LSI Medoence Corporation
Outcome results
None listed