Pharmacokinetics and Safety Following Administration of DWP16001
NCT ID: NCT05414591
Last Updated: 2022-07-13
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
38 participants
INTERVENTIONAL
2021-05-01
2021-08-01
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 group A
DWP16001 A mg 1T
DWP16001 drug A
1 tablet, Oral, once daily single dose
DWP16001 drug B
3 tablet, Oral, once daily single dose
Sequence group B
DWP16001 B mg 3T
DWP16001 drug A
1 tablet, Oral, once daily single dose
DWP16001 drug B
3 tablet, Oral, once daily single dose
Interventions
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DWP16001 drug A
1 tablet, Oral, once daily single dose
DWP16001 drug B
3 tablet, Oral, once daily single dose
Eligibility Criteria
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Inclusion Criteria
* Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
* Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
* Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.
Exclusion Criteria
* Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
* Clinical laboratory test values are outside the accepted normal range at screening
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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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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DW_DWP16001105
Identifier Type: -
Identifier Source: org_study_id
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