Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
NCT ID: NCT04064073
Last Updated: 2020-01-13
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
34 participants
INTERVENTIONAL
2019-08-14
2019-11-20
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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1
DWP16001
Tablets, Oral, once daily single dose
2
Metformin IR
Metformin IR 1000mg, Tablets, Oral, BID for 7 days
3
DWP16001+Metformin IR
Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
Interventions
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DWP16001
Tablets, Oral, once daily single dose
Metformin IR
Metformin IR 1000mg, Tablets, Oral, BID for 7 days
DWP16001+Metformin IR
Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
Eligibility Criteria
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Inclusion Criteria
* 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
* Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
* Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.
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
* Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
* Clinical laboratory test values are outside the accepted normal range at screening
19 Years
50 Years
MALE
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_DWP16001102
Identifier Type: -
Identifier Source: org_study_id
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