Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers
NCT ID: NCT03364985
Last Updated: 2019-08-21
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
123 participants
INTERVENTIONAL
2017-12-03
2019-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: DWP16001 Amg
DWP16001 Amg, tablets, orally, single dose administration
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 2: DWP16001 Bmg
DWP16001 Bmg, tablets, orally, single dose administration
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 3: DWP16001 Cmg
DWP16001 Cmg, tablets, orally, single dose administration
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 4: DWP16001 Dmg
DWP16001 Dmg, tablets, orally, single dose administration
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 5: DWP16001 Emg
DWP16001 Emg, tablets, orally, single dose administration
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 6: DWP16001 Fmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 7: DWP16001 Gmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 8: DWP16001 Hmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 9: DWP16001 Img
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Cohort 10: DWP16001 Jmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Interventions
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DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets
Dapagliflozin
Forxiga®
Eligibility Criteria
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Inclusion Criteria
2. Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 27.0.
3. Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study.
4. Eligible to participate in the study by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.
Exclusion Criteria
2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.
3. Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
4. Following laboratory abnormalities identified during the screening test:
* AST (SGOT), ALT (SGPT) \>1.5 upper limit of normal range
* Creatinine clearance calculated by the MDRD equation \< 90 mL/min
* Repeatedly confirmed QTc interval \> 450 ms
* Fasting serum glucose \> 110mg/dL or \< 70mg/dL
* Serum HbA1c \> 6.5 mg/dL
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_DWP16001001
Identifier Type: -
Identifier Source: org_study_id
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