Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs
Completed
- Conditions
- healthy male
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
- Japanese healthy male who is capable to understand and sign the informed consent
- 20-45 years of age
- BMI 17.6-26.4
- good health as determined by physical examination, vital signs and laboratory tests.
Exclusion Criteria
- history of allergy to any drugs
- medical attention within 2 months prior to participation
- 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
- donation of 400 mL or more of blood within 12 weeks prior to participation
- recent (past 4 months) participation in other clinical trial for investigational new chemical entity
- history of drug abuse
- alcohol abuse
- taking drugs or healthy foods which may affect drug metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method blood drug concentration tacrolimus, valacyclovir, candesartan cilexetil and their major metabolites
pharmacokinetic parameters Cmax, Tmax, AUC, T1/2, CL, etc.
- Secondary Outcome Measures
Name Time Method