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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: clarithromycin; Drug: Amoxicillin; Drug: YH4808; Drug: Nexium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01921647

YH4808-108

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 4 patient groups

YH4808, amoxicillin, clarithromycin

Experimental group

Description:

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

Treatment:

Drug: YH4808

Drug: Amoxicillin

Drug: clarithromycin

YH4808, amoxicillin and clarithromycin

Experimental group

Description:

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

Treatment:

Drug: YH4808

Drug: Amoxicillin

Drug: clarithromycin

YH4808 and amoxicillin

Experimental group

Description:

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

Treatment:

Drug: YH4808

Drug: Amoxicillin

nexium, amoxicillin and clarithromycin

Active Comparator group

Description:

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

Treatment:

Drug: Nexium

Drug: Amoxicillin

Drug: clarithromycin