Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
NCT ID: NCT04477369
Last Updated: 2020-07-29
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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UNKNOWN
PHASE1
28 participants
INTERVENTIONAL
2020-08-06
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
DWJ1439
300mg single dose
DWJ1464
300mg single dose
DWC202003
300mg single dose
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
DWJ1464
300mg single dose
DWC202003
300mg single dose
DWC202004
300mg single dose
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
DWJ1439
300mg single dose
DWC202003
300mg single dose
DWC202004
300mg single dose
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
DWJ1439
300mg single dose
DWJ1464
300mg single dose
DWC202004
300mg single dose
Interventions
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DWJ1439
300mg single dose
DWJ1464
300mg single dose
DWC202003
300mg single dose
DWC202004
300mg single dose
Eligibility Criteria
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Inclusion Criteria
* BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Exclusion Criteria
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
* Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
19 Years
ALL
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Kyung Hee University Medical Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Bo-Hyung Kim
Role: primary
Other Identifiers
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DW_DWJ1464101
Identifier Type: -
Identifier Source: org_study_id
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