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YH4808 Postprandial PK/PD Study in Healthy Subjects

NCT01761513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-04-15

No results posted yet for this study

Summary

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Conditions

  • Healthy

Interventions

DRUG

YH4808

Group1 1. adminitration of YH4808 dose1, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, qd for 2weeks

DRUG

YH4808

Group2 1. adminitration of YH4808 dose2, qd for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose1, bid for 2weeks

DRUG

YH4808

Group3 1. adminitration of YH4808 dose2, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of Nexium tab 40mg, bid for 2weeks

DRUG

YH4808

Group 4 1. adminitration of Nexium tab 40mg, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, bid for 2weeks

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Minsoo Park, Ph.D, M.D. · Yonsei University Health System(Severance Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-02-28
Completion
2014-02-28

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 NCT01761513 on ClinicalTrials.gov