Healthy subjects
Conditions
Interventions
TW-50411N-2, washout, original drug
original drug, washout,TW-50411N-2
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)People who receive enough explanation for this test drug and the aim and the content of this study, and who voluntarily obtain informed consent (2)18.5=<BMI<25.0(truncating the numbers beyond the first decimal point.) (3)People who comply with rules determined for this study (4)People who are judged as eligible based on the result of screening tests, their back ground(history, allergy, favorites, etc.), physical findings, physical examinations, ECG, clinical laboratory test and so on by principal or sub investigators (5)People who agree with appropriate contraception after the consent to the end of post-observation(14days after drug dosage in second period)
Exclusion criteria
Exclusion criteria: (1)People who have diseases under treatment (2)People who have or had any disease of heart, liver, kidney, metabolic, alimentary tract, blood, respiratory and psychology, and who are judged as not eligible by principal or sub investigators (3)People who are in clinical tests below 1)Platelets count is low 2)Plasma potassium is out of range 3)AST(GOT), ALT(GPT), total bilirubin beyond upper limit 4)HbA1c is beyond upper limit (4)People whose blood pressure is SBP>=140 or DBP>=90 in screening or before drug dosage in first period (5)People who have abnormal finding in chest X-ray photo at the examination before drug dosage in first period (6)People who have history or present illness of hypersensitivity or allergy for drugs (7)People who have dependence to drugs or alcohol and who are positive in urine drug test (8)People who are smoking or has history of smoking in 6 months. (9)People who are positive for infectious diseases test (10)People who have a history of stomach resection or any abdominal operation supposed to effect absorption for the drug. (11)People who were or will be given any drugs in another clinical trials in 12 weeks. (12)People who underwent or will undergo collecting blood more than 400ml of total blood in 12 weeks or 200ml of total blood in 2 weeks or component (plasma component or platelets component) collecting blood in 2 weeks. (13)People who have taken any drugs(prescription drug, OTC drug, herbal medicine, vitamins, and supplements) in 2 weeks before drug dosage or who will take nay drugs except test drugs before the end of this study (14)People who have taken or takes citrus fruits including grape fruits except lemon or their processed food in 2 weeks before drug dosage. (15)People who took or take food containing St johns wort 2 weeks before drug dosage. (16)People who will have taken or will take alcohol before 3 days before drug dosage. (17)People who are judged as not eligible by principal or sub investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax AUCt | — |
Countries
Japan
Contacts
Public ContactTatsuya Maruyama
The University of Tokyo Hospital Clinical Research Promotion Center
Outcome results
None listed