Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs

JRCT ID: jRCTs071230054

Registered date:28/08/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy male
• Date of first enrollment: 28/08/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

1. Single oral dose of tacrolimus hydrate, valacyclovir hydrochloride, candesartan cilexetil
2. Single oral dose of probiotics containing Bacillus subtilis, tacrolimus hydrate, valacyclovir hydrochloride, candesartan cilexetil

Outcome(s)

Primary Outcome

1. blood drug concentration (tacrolimus, valacyclovir, candesartan cilexetil and their major metabolites)
2. pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Yoshihara Tatsuya
• Secondary Sponsor: Ieiri Ichiro,Department of Pharmacy, Kyushu University Hospital