14C-acetaminophen microdose clinical trial using AMS

UMIN ID: UMIN000002084

Registered date:21/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 2009/06/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

coadministration of acetaminophen and probenecid
administration of acetaminophen alone

Outcome(s)

• Primary Outcome: detection from radioactive concentraions of plasma, urin and feces samples.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 45years-old
• Gender: Male
• Exclude criteria: the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions 1)peptic ulcer 2)dysemia 3)kidney stone 4)history of cardiac disease 5)imparment of liver or kidney functions 6)any medical condition that reqires medical attention 7) recent (past 4 months) participation in other clinical trial and the investigator determines this trial participation inadequate 8)history of allergy to acetaminophen and probenecid 9)history of aspirin indeced asthma 10)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 11)positive serologic reaction of syphilis, positive result of HIV test, HBsAg and HCVAb 12)history of multiple and recurring allergies to medicines or food 13)history of drug or alcoholabuse 14) the investigator determines this trial participation inadequate

Related Information

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