YH4808 Postprandial PK/PD Study in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: YH4808

• Registration Number: NCT01761513
• Lead Sponsor: Yuhan Corporation

Brief Summary

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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. Other exclusions apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	YH4808	-
Sequence 2	YH4808	-
Sequence 3	YH4808	-
Sequence 4	YH4808	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve of YH4808	Blood sampling during 0 ~ 24 hrs after administration
Peak plasma concentration of YH4808	Blood sampling during 0~24 hrs after administration

Secondary Outcome Measures

Name	Time	Method
Time to reach peak plasma concentration of YH4808	Blood sampling during 0 ~ 24 hrs after administration

Trial Locations

Locations (1)

Yonsei University Health System(Severance Hospital); 🇰🇷 Seoul, Seodaemun-gu,Sinchon-dong, Korea, Republic of