Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide

UMIN ID: UMIN000002220

Registered date:23/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 2009/07/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): oral administration of C14-tolbutamide

Outcome(s)

• Primary Outcome: general feasibility of microdose clinical trail using AMS based on evaluated data compared with known data and parameters.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 45years-old
• Gender: Male
• Exclude 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

Related Information

• Primary Sponsor: APDD
• Source(s) of Monetary Support: APDD