Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects
NCT ID: NCT01007019
Last Updated: 2014-07-10
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
134 participants
INTERVENTIONAL
2009-11-30
2012-03-31
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
BASIC_SCIENCE
DOUBLE
Study Groups
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YH4808 30mg
1.Single dose
2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 30mg
YH4808 30mg (single dose)
YH4808 50mg
1.Single dose
2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 50mg
YH4808 50mg (single dose)
YH4808 100mg
1.Single dose
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 100mg
YH4808 100mg (single dose)
YH4808 200mg
1.Single dose
2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 200mg
YH4808 200mg (single dose)
YH4808 400mg
1.Single dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808
YH4808 400mg (single dose)
YH4808 100mg(repeat doses)
1.Repeat doses
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 100mg (repeat dose)
YH4808 100mg (repeat dose)
YH4808 200mg(repeat doses)
1.Repeat doses
2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2)
YH4808 200mg (repeat dose)
YH4808 200mg (repeat dose)
YH4808 400mg(repeat doses)
1.Repeat dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 400 mg (repeat doses)
YH4808 400 mg (repeat doses)
YH4808 600mg
1.Single dose
2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 600mg
YH4808 600mg
YH4808 800mg
1.Single dose
2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 800mg (single dose)
YH4808 800mg (single dose)
Placebo
Placebo
10 volunteers will be administered matched placebo.
Esomeprazole 40mg
Esomeprazole 40mg
24 volunteers will be administered Esomeprazole 40mg
Interventions
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YH4808 100mg
YH4808 100mg (single dose)
YH4808 200mg
YH4808 200mg (single dose)
YH4808
YH4808 400mg (single dose)
YH4808 100mg (repeat dose)
YH4808 100mg (repeat dose)
YH4808 200mg (repeat dose)
YH4808 200mg (repeat dose)
YH4808 600mg
YH4808 600mg
YH4808 800mg (single dose)
YH4808 800mg (single dose)
YH4808 400 mg (repeat doses)
YH4808 400 mg (repeat doses)
Placebo
10 volunteers will be administered matched placebo.
Esomeprazole 40mg
24 volunteers will be administered Esomeprazole 40mg
YH4808 30mg
YH4808 30mg (single dose)
YH4808 50mg
YH4808 50mg (single dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who were determined to be appropriate through screening
* Weight: over 50kg, within ±20% of ideal body weight
* Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
Exclusion Criteria
* Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
* A history of hypersensitivity to drugs or clinically significant allergic disease
* Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
* Subjects who were unable to be applicable for pH meter catheter
* Subjects who had a history of drug abuse or who had a positive results on urine drug screening
* Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
* Subjects who participated in another clinical trial within 3 months before enrolling in this study
* Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
* Subjects who drank Over 21 units/week of alcohol or subjects who weren't able to stop drinking alcohol during the hospitalization
* Subjects who stopped smoking within 3 months before the treatment
* Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
* Subjects who had a beverage containing caffeine during the hospitalization
* H.pylori positive results on the Urease breath test(Only repeat doses)
* Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
20 Years
45 Years
MALE
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-Sang Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Clinical trials center, Seoul national university hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YCD142 (YH4808-101)
Identifier Type: -
Identifier Source: org_study_id
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