Overview

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