The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: YH4808 NF 100; Drug: YH4808 OF 200; Drug: YH4808 NF 200; Drug: YH4808 NF 400

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei Medical Center Severance Hospital Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. negative to Helicobacter pylori in 13C urea breath test
4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion Criteria:

1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
4. pregnant or lactating woman.
5. Other exclusions apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort1-YH4808 NF 100; 7 days repeat administration of YH4808 New Formulation 100mg after meal	Drug: YH4808 NF 100; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 OF 200; (Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration; Drug: YH4808 NF 200; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 NF 200; (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration; Drug: YH4808 NF 200; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 NF 400; 7 days repeat administration of YH4808 New Formulation 400mg after meal	Drug: YH4808 NF 400; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 100; 7 days repeat administration of YH4808 New Formulation 100mg before meal	Drug: YH4808 NF 100; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 200; (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration; Drug: YH4808 NF 200; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 OF 200; (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration; Drug: YH4808 NF 200; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 400; 7 days repeat administration of YH4808 New Formulation 400mg before meal	Drug: YH4808 NF 400; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort3-YH4808 OF 200; (Partial cross over design); 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner; 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort3-YH4808 OF 400; (Partial cross over design); 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner; 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed	Drug: YH4808 OF 200; The number of times : multiple-dose Rout : oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Cmax of YH4808	Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing	Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of YH4808	Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing	Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of M3	Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing	Day 1(Day 35), Day 7(Day 41)
The Cmax of M3	Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing	Day 1(Day 35), Day 7(Day 41)

Secondary Outcome Measures

Outcome Measure	Time Frame
the arithmetic mean of 24h intragastric pH monitoring	Day 1(Day7)~Day2(Day8)
the median of 24h intragastric pH monitoring	Day 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5	Day 1(Day7)~Day2(Day8)

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Min soo Park, Ph.D, M.D., Yonsei Medical Center Severance Hospital Clinical Trials Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (ESTIMATE): June 27, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: February 1, 2015

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: YH4808-111