Status:
COMPLETED
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
Eligibility Criteria
Inclusion
- healthy male/female aged 19 to 45 with body mass index(BMI) between 18 and 25kg/m2
- 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 ECG etc)
- Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
Exclusion
- 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 is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs
- Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
- Clinically significant abnormal values in diagnostic check within 28 days before the treatment(\>1.25 fold of normal upper limit in the levels of AST or ALT, \>1.5 fold of normal upper limit in the levels of Total bilirubin, \< 80ml/min of Cockcroft-Gault used creatinine clearance
- Subject has over QTc interval of 550 ms or PR interval of 210 ms or QRS interval of 120 ms or QT interval of 500 ms on baseline 12-lead ECG, as determined by the Investigator
- Subject who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
- Subject who participated in another clinical trail within 2 months before enrolling in this study
- subject who donated whole blood within 2 months or component blood within 1 month before the treatment
- Medically unacceptable contraception used during the clinical trial
- Subject who drank over 30g/day or were detected alcohol positive on test
- Subject who stopped smoking within 3 months before the treatment or weren't able to stop smoking during the hospitalization
- Subject who had a beverage containing caffeine during the hospitalization
- Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01870674
Start Date
August 1 2013
End Date
April 1 2015
Last Update
May 8 2015
Active Locations (1)
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1
Inje Busan Paik hospital
Busan, South Korea, 614-735