Healthy adult
Conditions
Interventions
Fecal sampling for 3 days before medication ---- take 3 capsules after each meal (total 135 mg wood creosote) (9 capsules per day, grand total 405 mg wood creosote) ---- Fecal sampling for 3 days afte
Sponsors
Taiko Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male female healthy volunteers above 20 and below 50 years of age when written informed consent is obtained. 2. Subjects who are judged as eligible in the screening test by the principal investigator 3. Subjects who realize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1.Subjects who have a disease under treatment 2.Subjects who have diarrhea with fever, bloody stool or continued mucus stool 3.Pregnant and lactating female, or subjects who are judged as pregnant 4.Subjects who have hypersensitivity or idiosyncrasy to drugs, in particular wood creosote, or those with a history of that 5.Subjects with constipation or diarrhea 6.Subjects who have more drinking habits than the appropriate range and excessive smoking habits 7.Subjects who used or took a medicine within one week before the first day of the study or those who need to use or take a medicine 8.Subjects who take foods for specified health uses , foods with function claims and foods with nutrient function claims (supplements in capsule form and others), excluding those who can stop taking those foods after informed consent) 9.Shift workers during the night 10.Subjects who cannot regularly consume three meals in the morning, noon, and evening, every day 11.Subjects who are planning to travel both domestically and abroad for one week before the first day of the study or during the study period 12.Subjects who cannot participate in the screening test and the study period (7 days), or who cannot visit on the prescribed date 13.Subjects who are unable to fill in their daily diaries during the prescribed period 14.Subjects who donated more than 200 mL of blood within one month before the first day of the study or subjects who have the schedule during the study period 15.Subjects who participated in other clinical trials within 12 weeks before the first day of the study and received medication 16.Subjects who are judged as ineligible to participate in the study for other reasons by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronological changes in the copy numbers of extracted DNA per unit mass (gram of feces used in extraction) as the change parameter of the intestinal flora. | — |
Countries
Japan
Contacts
Public ContactJunko Fujii
New Drug Research Center Inc. Clinical Research Development
Outcome results
None listed