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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02176668
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 10
• Duration (Months): 5
• Patients Per Site Per Month: 16.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: YH4808 NF 100; Drug: YH4808 OF 200; Drug: YH4808 NF 200; Drug: YH4808 NF 400	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Secondary Outcome Measures

1. the arithmetic mean of 24h intragastric pH monitoring [Day 1(Day7)~Day2(Day8)]

2. the median of 24h intragastric pH monitoring [Day 1(Day7)~Day2(Day8)]

3. The Duration of stomach maintained over pH4 or 5 [Day 1(Day7)~Day2(Day8)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei Medical Center Severance Hospital Clinical Trials Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT02176668
• Other Study ID Numbers: YH4808-111
• First Posted: Jun 27, 2014
• Last Update Posted: Jan 13, 2022
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Esomeprazole

Study Results

No Results Posted as of Jan 13, 2022