YH4808 Postprandial PK/PD Study in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: YH4808; Drug: YH4808; Drug: YH4808; Drug: YH4808

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu,Sinchon-dong
    • Seoul, Seodaemun-gu,Sinchon-dong, Korea, Republic of, 120-752
      • Yonsei University Health System(Severance Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1	Drug: YH4808; Group1; adminitration of YH4808 dose1, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, qd for 2weeks; Drug: YH4808; Group2; adminitration of YH4808 dose2, qd for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose1, bid for 2weeks; Drug: YH4808; Group3; adminitration of YH4808 dose2, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of Nexium tab 40mg, bid for 2weeks; Other Names: YH4808, Nexium; Drug: YH4808; Group 4; adminitration of Nexium tab 40mg, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, bid for 2weeks; Other Names: Nexium
Experimental: Sequence 2	Drug: YH4808; Group1; adminitration of YH4808 dose1, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, qd for 2weeks; Drug: YH4808; Group2; adminitration of YH4808 dose2, qd for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose1, bid for 2weeks; Drug: YH4808; Group3; adminitration of YH4808 dose2, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of Nexium tab 40mg, bid for 2weeks; Other Names: YH4808, Nexium; Drug: YH4808; Group 4; adminitration of Nexium tab 40mg, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, bid for 2weeks; Other Names: Nexium
Active Comparator: Sequence 3	Drug: YH4808; Group1; adminitration of YH4808 dose1, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, qd for 2weeks; Drug: YH4808; Group2; adminitration of YH4808 dose2, qd for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose1, bid for 2weeks; Drug: YH4808; Group3; adminitration of YH4808 dose2, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of Nexium tab 40mg, bid for 2weeks; Other Names: YH4808, Nexium; Drug: YH4808; Group 4; adminitration of Nexium tab 40mg, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, bid for 2weeks; Other Names: Nexium
Active Comparator: Sequence 4	Drug: YH4808; Group1; adminitration of YH4808 dose1, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, qd for 2weeks; Drug: YH4808; Group2; adminitration of YH4808 dose2, qd for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose1, bid for 2weeks; Drug: YH4808; Group3; adminitration of YH4808 dose2, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of Nexium tab 40mg, bid for 2weeks; Other Names: YH4808, Nexium; Drug: YH4808; Group 4; adminitration of Nexium tab 40mg, bid for 2weeks; wash-out period for 3weeks between period1 and period2; adminitration of YH4808 dose2, bid for 2weeks; Other Names: Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Time to reach peak plasma concentration of YH4808	Blood sampling during 0 ~ 24 hrs after administration

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Minsoo Park, Ph.D, M.D., Yonsei University Health System(Severance Hospital)

Publications and helpful links

General Publications

• Yoon S, Oh E, Park MS, Jang SB, Byun HM, Park H, Kim H, Kim CO. Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen. Transl Clin Pharmacol. 2021 Sep;29(3):150-159. doi: 10.12793/tcp.2021.29.e15. Epub 2021 Sep 17.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: YH4808-107