Healthy adults Sample collection for evaluating analysis and sampling methods for Anti-doping
Conditions
Interventions
The subject will be admitted to the hospital, and blood and urine collection will begin the next day. Test drug will be assigned to the subject and administered. Blood and urine collection will contin
Sponsors
Okano Masato
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 35 years (at the time when consent is given) 2) BMI at the time of prior examination : Males 18.5 or more and less than 25.0 3) Individuals who the principal or subinvestigator believes to be acceptable for the study
Exclusion criteria
Exclusion criteria: 1) Those who have experienced allergic symptoms due to drugs. 2) Those suspected of having an infectious disease, including the new coronavirus. 3) Those currently undergoing treatment for any disease or those who may undergo treatment during the study period. 4) Those who are alcoholic or drug dependent, or have a history of depression. 5) Those with a history of the following diseases or those suspected of having them: The RMP overview lists "hematopoietic malignancies, thromboembolism, and reproductive and developmental toxicity" as important potential risks, and individuals with a history of or risk factors for related diseases, or those suspected of having such diseases, should be excluded. 6) Those who have used prescription drugs or over-the-counter drugs within 5 weeks of taking the study drug 7) Those who have used supplements, western medicine, or other drugs within 1 week of taking the test drug. Those who have consumed food containing St. John's wort, grapefruit, or processed products thereof. 8) Those who have received other investigational or study drugs within 16 weeks of the administration of the study drug, or those who have received investigational or study drugs containing approved ingredients within 12 weeks. 9) Those who have had 200mL or more of blood drawn or transfused within 30 days of the administration of the study drug, or 400mL or more within 90 days, or those who have donated blood components within 14 days. 10) Those who weigh less than 50kg at the time of the pre-examination, and those with Hb value of 16 or more and Ht value of 50% or more for study drug-1 to study drug-2. 11) Those whose urine collected during the pre-test was found to contain prohibited doping substances or substances that affect doping tests 12) Those who consume excessive amounts of alcohol on a daily basis, and those who do not agree to refrain from alcohol consumption during the test period 13) Those who are deemed inappropriate for participation in this study by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of sample collection method: Sample collection time, type and amount of sample collected | — |
Secondary
| Measure | Time frame |
|---|---|
| Detectable period of unchanged and metabolites of study drugs: Sample collection time, type and amount of sample collected | — |
Contacts
Public ContactMitsuhiko Sato
LSI Medience Coporation Anti-Doping Laboratory
Outcome results
None listed