A Randomized, Open Label, Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 after Postprandial Oral Administration in Healthy Volunteers

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0000695
• 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: 20

Inclusion Criteria

1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
3. Subject who shows negative reaction of UBT(Urea Breath Test)
4. 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, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
6. Volunteers 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 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 symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
4. Sitting blood pressure meeting the following criteria at screening:
150 = systolic blood pressure =100 (mmHg) and
100 = diastolic blood pressure = 60 (mmHg) amd
5. Subject who has AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit at the time of screening
6. Subject who has history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
7. Subject who participated in any other clinical trials within two months prior to the first administration of Investigational Product
8. Subject who donated whole blood within 2 months prior to the first administration of Investigational Product, or donated blood components or received transfusion within 1 month prior to the first administration of Investigational Product
9. Subject who drink continuously (over 3 units/day, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
10.Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Study A - 1) AUC0-12h (AUCss,t), Cmax (Css,max) / 2) AUC0-24h (AUCss,t), Cmax (Css,max) ;Study B - AUC0-12h (AUCss,t), Cmax (Css,max)

Secondary Outcome Measures

Name	Time	Method
Study A - Tmax (Tss,max) and Css,min, Accumulation index(AI), Fluctuation(F) ;Study B - Tmax (Tss,max) and Css,min, Accumulation index(AI), Fluctuation(F)