Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
NCT ID: NCT01941199
Last Updated: 2013-11-27
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
2013-07-31
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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D → M → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
D → D+M → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
M → D → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
M → D+M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
D+M → M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
D+M → D → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
DA-1229
metformin
DA-1229 + metformin
Interventions
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DA-1229
metformin
DA-1229 + metformin
Eligibility Criteria
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Inclusion Criteria
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Exclusion Criteria
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.
20 Years
45 Years
MALE
Yes
Sponsors
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Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Center, Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA1229_DIM_I
Identifier Type: -
Identifier Source: org_study_id
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