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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Microdose

Group Type EXPERIMENTAL

YH4808 PO and [14C]-YH4808 IV

Intervention Type DRUG

Interventions

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YH4808 PO and [14C]-YH4808 IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes