Pharmacokinetic study of single oral administration of Ninjin'yoeito.
- Conditions
- fatigue,poor appetite etc.
- Registration Number
- JPRN-jRCT2031200439
- Lead Sponsor
- Orimoto Mie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 8
(1)Japanese
(2)Subjects body mass index is between 18.5 and 25.0.
(3)Willing and able to provide written, signed informed concent.
(1)Subjects with a history of allergic reactions to drugs and foods.
(2)Subjects who have participated in other clinical trial within the past 16 weeks starting from the hospitalization date (two days before test drug administration).
(3)Subjects who have had their blood drawn or donated >200mL of blood within the past 12 weeks starting from the hospitalization date (two days before test drug administration).
(4)Subjects with a history of significant organopathy.
(5)Subjects with a history of digestive disease. (peptic ulcer, reflux esophagitis etc.)(excepting for the history of appendicitis)
(6)Subjects with a history of digestive tract resection. (excepting for appendicitectomy)
(7)Subjects who cannot quit drinking or smoking from the hospitalization date (two days before test drug administration) to the leaving hospital.
(8)Subjects who cannot interrupt drugs other than the test drug or supplements from 7 days before test drug administration to the end of the clinical trial.
(9)Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator.
(10)Subjects who have any of positive HCV antibody, HBs antigen, HIV antigen antibody, TP antibody.
(11)Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method