The exploration for pharmacodynamics and pharmacokinetic interaction between YH4808, amoxicillin and clarithromycin in healthy subjects

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0000888
• Lead Sponsor: Yuhan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
2.Subject who has no congential, chronic disease and disease symptoms in medical examination result
3.Subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons including ther 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 symtom (e.g. crohn's disease, ulcer etc except appendectomy or simple for herina)
4.Other exclusions apply

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin;AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

Secondary Outcome Measures

Name	Time	Method
Cmax of M8; AUCinf of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin;AUClast of M8; t1/2 of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin;Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin