healthy volunteer
Conditions
Interventions
oral administration of C14-tolbutamide
Sponsors
APDD
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: the investigators must ensure that all subjects being considerd meet the following inclusion criteria 1)capable to understand and sign the informed consent. 2)20-45 years of age 3)BMI 18.5-25.0 4)good health as determined by physical examination, vital signs and laboratory tests. 5)CYP2C9 SNP's classified in EM(*1/*1) or IM(*1/*3)
Exclusion criteria
Exclusion criteria: the investigators must ensure that all subjects being considered meet the following exclusion criteria or conditions 1)diabetes or blood glucose abnormality 2)dysemia 3)history of cardiac disease 4)impairmant of liver or kidney functions 5)any medical condition that reqires medical attention 6)recent (past 4 months) participation in other clinical trial and the investigator determines this trial participation inadequate 7)history of allergy to tolbutamide 8)donation of 400mL or more of blood within 3 months prior to participation, donation of 200mL or more of blood within 1 month prior to participation, or donation of component blood within 2 weeks prior to participation 9)positive serologic reaction of syphilis, positive results of HIV test, HBsAg and HCVAb 10)history of multiple and recurning allergies to medicines or food 11)history of drug or alcohol abuse 12)the investigator determines this trial participation inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| general feasibility of microdose clinical trail using AMS based on evaluated data compared with known data and parameters. | — |
Countries
Japan
Contacts
Public ContactKainuma Michiko
Sekino Clinical Pharmacology Clinic Sekino Clinical Pharmacology Clinic
Outcome results
None listed