Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
NCT ID: NCT05574374
Last Updated: 2023-04-04
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
36 participants
INTERVENTIONAL
2022-09-21
2023-03-06
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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Cohort 1
* Treatment A: DWC202202 1 tablet qd for 7days
* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
DWP14012
Potassium-competitive acid blocker
DWC202202
Clopidogrel Bisulfate
DWC202203
Proton pump inhibitor
Cohort 2
* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
* Treatment A: DWC202202 1 tablet qd for 7days
* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
DWP14012
Potassium-competitive acid blocker
DWC202202
Clopidogrel Bisulfate
DWC202203
Proton pump inhibitor
Cohort 3
* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
* Treatment A: DWC202202 1 tablet qd for 7days
DWP14012
Potassium-competitive acid blocker
DWC202202
Clopidogrel Bisulfate
DWC202203
Proton pump inhibitor
Interventions
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DWP14012
Potassium-competitive acid blocker
DWC202202
Clopidogrel Bisulfate
DWC202203
Proton pump inhibitor
Eligibility Criteria
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Inclusion Criteria
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Exclusion Criteria
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, antibiotics, etc.
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
* Subjects who are smoking
19 Years
50 Years
ALL
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DW_DWP14012110
Identifier Type: -
Identifier Source: org_study_id
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