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

Seoul National University

Status and phase: Completed; Early Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: YH4808 PO and [14C]-YH4808 IV

Study type: Interventional

Funder types: Other

Identifiers

NCT02072447

Microdose_01(YH4808-110(I))

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Microdose

Experimental group

Treatment:

Drug: YH4808 PO and [14C]-YH4808 IV