Status:
COMPLETED
The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
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, amox...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01921647
Start Date
July 1 2013
End Date
November 1 2013
Last Update
December 3 2013
Active Locations (1)
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1
Yonsei University Severance Hospital
Seoul, South Korea