Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and [14C]-labeled intravenous microdoses.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

Inclusion Criteria:

• healthy male subject aged 20 to 45 at screening

• subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0

• subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

• subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor

• clinically significant allergic disease (except for mild allergic rhinitis)

• subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start

• subjects considered unsuitable for inclusion by the investigator