Healthy
Conditions
Keywords
safety/tolerability and pharmacokinetics/pharmacodynamics
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
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin | pre dose, 16 times after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin | pre dose, 16 times after dosing |
Countries
South Korea
Outcome results
None listed