on-blinded safety verification test using a dose of the test food TK61406 five times higher than that intended for healthy individuals
- Conditions
- Healthy person
- Registration Number
- JPRN-jRCT1091220206
- Lead Sponsor
- Tokai Pickling Co.,Ltd.Yasuhumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method