Healthy adults Sample collection for evaluating analysis and sampling methods for Anti-doping
Conditions
Interventions
Blood sampling begins on the day following the subject's hospitalization and one of the Study Drug-1-Study Drug-12 (1 tablet of Evrenzo tablet 50 mg: roxadustat 50 mg, 1 tablet of Enaroy tablet 2 mg:
Sponsors
Ikushima Ippei
Okano Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age: 20 to 35 years (at the time when consent is given) b. BMI at the time of prior examination : Males 18.5 or more and less than 25.0, Female 17.6 more and less than 26.4 c. Individuals who the principal or subinvestigator believes to be acceptable for the study
Exclusion criteria
Exclusion criteria: a. Those who have a history of allergic symptoms due to drugs; b. Those who are suspected of having an infectious disease, including SARS CoV 2 infection; c. Those who are undergoing any therapy now or will undergo any therapy during the study period; d. Those who were or are alcoholic, drug addicted, or depressed; e. Those who have a history of or are suspected of having one of the following diseases; Study Drug 1 to Study Drug 5: Cerebral infarction, myocardial infarction, thromboembolism such as pulmonary embolism, cardiovascular disease, stroke, central hypothyroidism, hypertension, malignant tumor, proliferative diabetic retinopathy, macular edema, exudative age related macular degeneration, retinal vein occlusion and liver dysfunction Study Drug 6 to Study Drug 9: myocardial infarction, pulmonary infarction, cerebral infarction, hypertension and hyperkalemia Study Drug 10: Hyponatremia, habitual or psychogenic polydipsia, fluid retention requiring treatment with diuretics, syndrome of inappropriate secretion of antidiuretic hormone, renal dysfunction, cardiovascular disease with hypertension, severe disease, Arteriosclerosis, coronary artery thrombosis, angina pectoris, heart failure and anterior pituitary insufficiency Study Drug 11: Congenital long QT syndrome, congestive heart failure, bradyarrhythmia, hypokalemia, hypomagnesemia and other electrolyte abnormalities, hypertension, liver dysfunction, adrenal cortical dysfunction Study Drug 12: Pulmonary edema, congestive heart failure, renal dysfunction such as renal failure with oliguria or anuria, intracranial hemorrhage, hypernatremia, hyperchloremia, bleeding diathesis f. Those who have a history of using ethical or over the counter drugs within five weeks ahead of administrating the study drug; g. Those who have a history of consuming supplements, foods containing St. John's Wort, grapefruit, or its processed products within one week ahead of administrating the study drug h. Those who have a history of treatment with other investigational or study drugs within 16 weeks before administration of the study drug or treatment with other investigational or study drugs containing approved ingredients within 12 weeks before administration of the study drug; i. Those who have a history of having 200 mL or more of blood or 400 mL or more of blood sampled within 30 or 90 days before administrating the study drug, respectively, or a history of blood component transfusion within 14 days or whole blood transfusion within 90 days before administrating the study drug; j. Those who weigh less than 50 kg for a male and less than 40 kg for a female at the time of preliminary
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 | — |
Contacts
Public ContactMitsuhiko Sato
LSI Medience Corporation
Outcome results
None listed