Postmarketing clinical traial of Maoto (TJ-27).
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT1080223758
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 4
(1) Japanese
(2) Subject body mass index (BMI) is between 18.5 and 25.0 kg/m2
(3) Willing and able to provide written, signed informed consent
(1) Subjects with a history of allergic reactions to drugs and foods.
(2) Subjects who have participated in another clinical trial within the past 16 weeks starting from the hospitalization date.
(3) Subjects who have had their blood drawn or donated >400mL of blood within the past 12 weeks starting from the hospitalization date.
(4) Subjects with history of significant hepatic, cardiovascular or hematological disease
(5) Subjects who can not quit drink or smoking from 2 days before the hospitalization date to the end of the hospitalization period.
(6) Subjects who can not interrupt drugs other than the test drug or who has taken it from 6 days before the hospitalization date to the end of the hospitalization period.
(7) Subjects who can not interrupt drinks, foods or supplements* containing crud drugs and foods below or ingest them from 2 days before hospitalization date to the end of hospitalization period.
Peach kernel, apricot kernel, cinnamon, ephedra herb, glycyrrhiza, foods containing glycyrrhiza [marked in raw material name], cinnamon, garlic, citrus fruits (grapefruit, oranges, oranges etc.), caffeine, alcohol, and seeds, pulp and leaves of plants Rosaceae Cerasus plants (apricot, plum, peach, asian plum, almond etc.) and eriobotrya (loquat).
(8) Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator.
(9) Subjects who are positive for HCV antibody, HBs antigen, and HIV antigen antibody.
(10) Subjects who are ingesting prohibited drugs amphetamine, methamphetamine, or ingested in the past.
(11) Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.
*In addition, supplements are any products that contain vitamins, minerals, herbs, amino acids and are intended to supplement normal diet.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>(1) Estimation and identification of unidentified compounds in plasma, and safety.<br>(2) Targeted metabolome, blood concentration of major compounds of TJ-27 and correlation between them and body temperature and perspiration as phenotype.
- Secondary Outcome Measures
Name Time Method other<br>Unset