The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01921647
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description YH4808, amoxicillin, clarithromycin YH4808 single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin YH4808, amoxicillin, clarithromycin Amoxicillin single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin YH4808, amoxicillin, clarithromycin clarithromycin single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin YH4808, amoxicillin and clarithromycin YH4808 7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication YH4808, amoxicillin and clarithromycin Amoxicillin 7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication YH4808, amoxicillin and clarithromycin clarithromycin 7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication YH4808 and amoxicillin YH4808 7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication YH4808 and amoxicillin Amoxicillin 7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication nexium, amoxicillin and clarithromycin Nexium BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication nexium, amoxicillin and clarithromycin Amoxicillin BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication nexium, amoxicillin and clarithromycin clarithromycin BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
- Primary Outcome Measures
Name Time Method Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin pre dose, 16 times after dosing
- Secondary Outcome Measures
Name Time Method Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin pre dose, 16 times after dosing
Trial Locations
- Locations (1)
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of