Healthy person
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Strain TK61406
Dose form / Japanese Medical Device Nomenclature:ORAL SOLUTION
Route of administration / Site of application:ORAL
Dose per administration:12.
Sponsors
Tokai Pickling Co.,Ltd.
Yasuhumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda
1,Contract Research Organization
Medical Fusion Co.,Ltd.
Hiromichi Hayashi, Yukari Hayashi, Toru Urakawa, Haruka Suminoya
2.Site Management Organization
Medical Fusion Co.,Ltd.
Risa Nakamura, Emiko Nakata, Azusa Yoshida
3.Clinical trial enforcement medical institution
MEDOC Medical Dock&Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. 1) Men and women aged more than 20 years, less than 45 years at the time of giving informed consent. 2) A person of Japanese nationality, and obvious Asian descent. 3) A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. 4) A person who has freely given consent and has understood the purpose of the study. 5) BMI = body weight (kg) / (height [m])2 Men: BMI +- 20% of the standard value (22) (range: 17.6 to 26.4) Women: BMI +- 20% of the standard value (21) (range: 16.8 to 25.2) 6) Blood pressure Systolic blood pressure: less than 130 mmHg Diastolic blood pressure: less than 85 mmHg 7) Pulse rate 50-100 times/minute 8) Body temperature 35.5 - 37.0oC 9) Excessive exercise can prevent a person from participating in the clinical study. 10) Excessive eating can prevent a person from participating in the clinical study. 11) Participant who understands that clinical visits are mandatory during the study period. 12) A bowel movement at the same time every day must be confirmed for more than 5 days by records in diary from -7 day to -1 day.
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to subjects. 1) A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion. 2) A person with a lengthy surgical history, including gastrectomy, gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient. 3) A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded). 4) A person with tattoo. 5) A person with hypersensitivity or idiosyncrasy, such as food allergies. 6) A person with alcohol or drug dependency. 7) A person who has participated in other clinical trials within 12 weeks (84days) of giving informed consent. 8) A person who has donated 400 ml of blood within 12 weeks (84 days), 200 ml of blood within 4 weeks (28 days), or a blood component (plasma or platelets) within 2 weeks (14 days) of giving informed consent. 9) A person trying to become pregnant within the clinical study period. 10) Nursing or pregnant woman. 11) A person whose diagnosis requires treatment of mental illness by a clinical investigator. 12) A person who is unable to comply with administrative matters during the clinical study. 13) Other people, who are determined ineligible by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.) and changes in clinical laboratory values from the baseline evaluation (visit0) to the second evaluation (visit2) or post evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| We verified the effects of "TK61406" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.), interleukin-12 and changes in clinical laboratory values from the baseline evaluation (visit0) to the second evaluation (visit2) or post evaluation. | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion CO.,LTD.
Outcome results
None listed