Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study
Early Phase 1
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Drug: YH4808 PO and [14C]-YH4808 IV
- Registration Number
- NCT02072447
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and \[14C\]-labeled intravenous microdoses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Microdose YH4808 PO and [14C]-YH4808 IV -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of