The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects
NCT ID: NCT02176668
Last Updated: 2022-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2014-06-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort1-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg after meal
YH4808 NF 100
The number of times : multiple-dose Rout : oral administration
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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
Cohort1-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg after meal
YH4808 NF 400
The number of times : multiple-dose Rout : oral administration
Cohort2-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg before meal
YH4808 NF 100
The number of times : multiple-dose Rout : oral administration
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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
Cohort2-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg before meal
YH4808 NF 400
The number of times : multiple-dose Rout : oral administration
Cohort3-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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Cohort3-YH4808 OF 400
(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
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Interventions
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YH4808 NF 100
The number of times : multiple-dose Rout : oral administration
YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
YH4808 NF 400
The number of times : multiple-dose Rout : oral administration
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
55 Years
ALL
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Min soo Park, Ph.D, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei Medical Center Severance Hospital Clinical Trials Center
Locations
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Yonsei Medical Center Severance Hospital Clinical Trials Center
Seoul, , South Korea
Countries
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Other Identifiers
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YH4808-111
Identifier Type: -
Identifier Source: org_study_id
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