Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs
- Conditions
- healthy male
- Registration Number
- JPRN-jRCTs071230054
- Lead Sponsor
- Yoshihara Tatsuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 10
1. Japanese healthy male who is capable to understand and sign the informed consent
2. 20-45 years of age
3. BMI 17.6-26.4
4. good health as determined by physical examination, vital signs and laboratory tests.
1. history of allergy to any drugs
2. medical attention within 2 months prior to participation
3. donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4. donation of 400 mL or more of blood within 12 weeks prior to participation
5. recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6. history of drug abuse
7. alcohol abuse
8. taking drugs or healthy foods which may affect drug metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method