Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
NCT ID: NCT04490434
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
110 participants
INTERVENTIONAL
2020-06-19
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1, A (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Celecoxib
Celecoxib 200mg, bid
Cohort 1, B (DWP14012/Celecoxib)
Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Celecoxib
Celecoxib 200mg, bid
Cohort 2, C (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Naproxen
Naproxen 500mg, bid
Cohort 2, D (DWP14012/Naproxen)
Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Naproxen
Naproxen 500mg, bid
Cohort 3, E (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Meloxicam
Meloxicam 15mg, qd
Cohort 3, F (DWP14012/Meloxicam)
Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
DWP14012
DWP14012 40mg, bid
Meloxicam
Meloxicam 15mg, qd
Interventions
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DWP14012
DWP14012 40mg, bid
Celecoxib
Celecoxib 200mg, bid
Naproxen
Naproxen 500mg, bid
Meloxicam
Meloxicam 15mg, qd
Eligibility Criteria
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Inclusion Criteria
* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Exclusion Criteria
* Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
19 Years
50 Years
MALE
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Jang In-Jin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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In-Jin Jang, MD, Ph.D
Role: primary
References
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Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
Other Identifiers
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DW_DWP14012005
Identifier Type: -
Identifier Source: org_study_id
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