The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects (YH4808-108)

December 2, 2013 updated by: Yuhan Corporation

The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
  2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  3. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc)

Exclusion Criteria:

  1. Subject who is hypersensitive to components contained in YH4808 or this drug
  2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
  3. Subject who has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
  4. Other exclusions apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YH4808, amoxicillin, clarithromycin
single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
Drug: Amoxicillin
Other Names:
  • experimental drug
Drug: clarithromycin
Other Names:
  • experimental drug
Drug: YH4808
Other Names:
  • experimental drug
Experimental: YH4808, amoxicillin and clarithromycin
7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
Drug: Amoxicillin
Other Names:
  • experimental drug
Drug: clarithromycin
Other Names:
  • experimental drug
Drug: YH4808
Other Names:
  • experimental drug
Experimental: YH4808 and amoxicillin
7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
Drug: Amoxicillin
Other Names:
  • experimental drug
Drug: YH4808
Other Names:
  • experimental drug
Active Comparator: nexium, amoxicillin and clarithromycin
BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
Drug: Amoxicillin
Other Names:
  • experimental drug
Drug: clarithromycin
Other Names:
  • experimental drug
Drug: Nexium
Other Names:
  • active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
Time Frame: pre dose, 16 times after dosing
pre dose, 16 times after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
Time Frame: pre dose, 16 times after dosing
pre dose, 16 times after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Min soo Park, Ph.D, M.D., Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH4808-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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