Gastroesophageal Reflux Disease
Conditions
Keywords
absolute bioavailability,, microdose,, AMS
Brief summary
This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and \[14C\]-labeled intravenous microdoses.
Interventions
DRUGYH4808 PO and [14C]-YH4808 IV
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute bioavailability (Fpo) | predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48, 96, 144, 216 hours post-dose |
Countries
South Korea
Outcome results
None listed