The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
NCT ID: NCT04914221
Last Updated: 2021-06-14
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
42 participants
INTERVENTIONAL
2021-03-13
2021-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
JLP-2002
administration of JLP-2002
Comparator
administration of comparator
Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
JLP-2002
administration of JLP-2002
Comparator
administration of comparator
Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
JLP-2002
administration of JLP-2002
Comparator
administration of comparator
Interventions
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JLP-2002
administration of JLP-2002
Comparator
administration of comparator
Eligibility Criteria
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Inclusion Criteria
* BMI 18.5 \~ 27.5 kg/m2
* Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial
Exclusion Criteria
* Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
* Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
* Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
* Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
* Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
* In the case of women, those who do not show a negative response on the pregnancy test
* Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
19 Years
55 Years
ALL
Yes
Sponsors
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Jeil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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JLP-2002-101-PK
Identifier Type: -
Identifier Source: org_study_id
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