Healthy adult subjects Sample collection for evaluating analysis and sampling methods in antidoping
Conditions
Interventions
Any one of the study drug Bastarel F tablet 3 mg, Sosegon tablet 25 mg and Tramal OD tablet 25 mg is administered orally as a single dose to the subject after breakfast, and urine and blood samples ar
Sponsors
LSI Medience Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) BMI more than 18.5 and less than 25.0 2) 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) Those who have had allergic symptoms due to drugs 2) Alcohol or drug addicts (including past history) 3) Within 2 weeks of the administration of the study drug, those who used medicinal products, over-the-counter drugs and those who consumed supplements, foods containing St. John's wort, grapefruit, or their processed products 4) A person who may be treated for any disease or during the study period 5) Those who received the study drug or study drug within 16 weeks of the study drug administration, and also study drug administration, or those who received the study drug containing the approved ingredients within 12 weeks of the day 6) Person who received blood collection under the following conditions for blood donation etc. 200 mL or more within 4 weeks of administration, 400 mL or more within 12 weeks of administration(In the case of the component blood donation, within 14 days of the administration day regardless of the blood collection volume) 7) Person who weighs less than 50 kg (at the time of prior examination) 8) Those who have a history of heart disease, liver disease, kidney disease, or who have high blood pressure, depression, mania, other psychiatric disorders, epilepsy, sleep related disease or history 9) Persons who were considered by the Study Investigator or Investigator as inappropriate for this study
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 test drugs: Sample collection time, type and amount of sample collected | — |
Countries
Japan
Contacts
Public ContactMitsuhito Sato
LSI Medience Corporation
Outcome results
None listed