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The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

NCT ID: NCT01921647

Last Updated: 2013-12-03

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

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Keywords

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safety/tolerability and pharmacokinetics/pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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YH4808, amoxicillin, clarithromycin

single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin

Group Type EXPERIMENTAL

YH4808

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

clarithromycin

Intervention Type DRUG

YH4808, amoxicillin and clarithromycin

7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication

Group Type EXPERIMENTAL

YH4808

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

clarithromycin

Intervention Type DRUG

YH4808 and amoxicillin

7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication

Group Type EXPERIMENTAL

YH4808

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

nexium, amoxicillin and clarithromycin

BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication

Group Type ACTIVE_COMPARATOR

Nexium

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

clarithromycin

Intervention Type DRUG

Interventions

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YH4808

Intervention Type DRUG

Nexium

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

clarithromycin

Intervention Type DRUG

Other Intervention Names

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experimental drug active comparator experimental drug experimental drug

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min soo Park, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei University Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Park H, Kim CO, Kim M, Lim Y, Lee WY, Yoon S, Park MS. Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):136-146. doi: 10.12793/tcp.2020.28.e16. Epub 2020 Sep 23.

Reference Type DERIVED
PMID: 33062627 (View on PubMed)

Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T. Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects. Transl Clin Pharmacol. 2020 Mar;28(1):55-65. doi: 10.12793/tcp.2020.28.e5. Epub 2020 Mar 31.

Reference Type DERIVED
PMID: 32274381 (View on PubMed)

Other Identifiers

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YH4808-108

Identifier Type: -

Identifier Source: org_study_id