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Completed

NCT Number: NCT01921647

The PK and PD 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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
  • Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  • 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

  • Subject who is hypersensitive to components contained in YH4808 or this drug
  • 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
  • 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)
  • Other exclusions apply

Treatment and study plan

YH4808

Drug

Other names: experimental drug

Nexium

Drug

Other names: active comparator

Amoxicillin

Drug

Other names: experimental drug

Clarithromycin

Drug

Other names: experimental drug

Primary outcomes

  1. Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

    Time frame: pre dose, 16 times after dosing

Secondary outcomes

  1. Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

    Time frame: pre dose, 16 times after dosing

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Acronym: YH4808-108

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2013
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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