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Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

NCT01520012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-07-24

No results posted yet for this study

Summary

The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

YH4808 100 mg

Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days

DRUG

YH4808 100 mg

Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days

DRUG

YH4808 300 mg

Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)

DRUG

YH4808 300 mg

Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)

DRUG

YH4808 300 mg

Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520012 on ClinicalTrials.gov