Healthy volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : TJ-27 [Tsumura maoto Extract Granules (for prescription)]
INN of investigational material : Maoto extract
Therapeutic category code : 52- Chinese medicin
Sponsors
Tsumura & Co.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety exploratory pharmacokinetics pharmacodynamics (1) Estimation and identification of unidentified compounds in plasma, and safety. (2) Targeted metabolome, blood concentration of major compounds of TJ-27 and correlation between them and body temperature and perspiration as phenotype. | — |
Secondary
| Measure | Time frame |
|---|---|
| other Unset | — |
Countries
Japan
Outcome results
None listed