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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: YH4808 NF 100; Drug: YH4808 OF 200; Drug: YH4808 NF 400; Drug: YH4808 NF 200

• Registration Number: NCT02176668
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-02
• Last Update Submitted: 2021-12-26
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort1-YH4808 NF 100	YH4808 NF 100	7 days repeat administration of YH4808 New Formulation 100mg after meal
Cohort1-YH4808 OF 200	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
Cohort1-YH4808 OF 200	YH4808 NF 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
Cohort1-YH4808 NF 200	YH4808 OF 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
Cohort2-YH4808 OF 200	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
Cohort2-YH4808 OF 200	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
Cohort3-YH4808 OF 200	YH4808 OF 200	(Partial cross over design) 1. 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 2. 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
Cohort1-YH4808 NF 400	YH4808 NF 400	7 days repeat administration of YH4808 New Formulation 400mg after meal
Cohort2-YH4808 NF 100	YH4808 NF 100	7 days repeat administration of YH4808 New Formulation 100mg before meal
Cohort1-YH4808 NF 200	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
Cohort2-YH4808 NF 400	YH4808 NF 400	7 days repeat administration of YH4808 New Formulation 400mg before meal
Cohort2-YH4808 NF 200	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
Cohort2-YH4808 NF 200	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
Cohort3-YH4808 OF 400	YH4808 OF 200	(Partial cross over design) 1. 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 2. 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Yonsei Medical Center Severance Hospital Clinical Trials Center; 🇰🇷 Seoul, Korea, Republic of