pharmacokinetic study of TW-50411N-2
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000039823
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 26
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax AUCt
- Secondary Outcome Measures
Name Time Method