Status:
COMPLETED
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.
Eligibility Criteria
Inclusion
- Healthy male adults aged 19 to 50 years at the time of screening test
- 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
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- 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
- Other exclusive inclusion criteria, as defined in the protocol
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04064073
Start Date
August 14 2019
End Date
November 20 2019
Last Update
January 13 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea