Healthy adult subjects Sample collection for evaluating analysis and sampling methods in antidoping
Conditions
Interventions
A INOLIN Tablets 3mg is administered orally to the each subject as a test drug, twice a day after breakfast and lunch and urine are collected from the test subjects.
Sponsors
LSI Medience Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese person 2)male: more than 50kg, BMI more than 18.5 and less than 25.0 3)female: more than 40kg, BMI more than 17.6 and less than 26.4 4)Person who were judged to be appropriate to participate in this study by the principal investigator or the Sub-investigator.
Exclusion criteria
Exclusion criteria: 1)Hypersensitivity to drugs, 2)A history of alcoholism or drug addiction, 3)Supplement, grapefruit or its products, or foods containing Hypericum perforatum consumed and Ethical or OTC pharmaceuticals administrated within two weeks before scheduled administration of the study drug, 4)People who have the possibility of receiving treatment, 5)Any investigational drug or the study drug administrated within 16 weeks and or any preparation containing the same ingredients as the test drug within 12 weeks before scheduled administration of the study drug, 6)Not less than 200 mL of blood is collected within 4 weeks or not less than 400 mL of blood is collected within 12 weeks before scheduled administration of the study drug, 7)A history of hyperthyroidism, hypertension, heart disease and diabetes or persons with symptoms of these disease, 8)Person who were judged to be inappropriate to participate in this study by the principal investigator or the Sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detectable period of unchanged drug and metabolites of the test drug, etc.: time, type, and amount of sample collected | — |
Countries
Japan
Contacts
Public ContactMitsuhiko Sato
LSI Medience Corporation
Outcome results
None listed