NCT04064073CompletedPhase 1
A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults
Daewoong Pharmaceutical Co. LTD.1 site in 1 country34 target enrollmentStarted: August 14, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Cmax of DWP16001
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male adults aged 19 to 50 years at the time of screening test
- •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 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
Arms & Interventions
1
Experimental
Intervention: DWP16001 (Drug)
2
Experimental
Intervention: Metformin IR (Drug)
3
Experimental
Intervention: DWP16001+Metformin IR (Drug)
Outcomes
Primary Outcomes
Cmax of DWP16001
Time Frame: 0-72 hours
Peak Plasma Concetration
Cmax,ss of Metformin
Time Frame: 0-144 hours
Peak Plasma Concetration at steady-state
AUClast of DWP16001
Time Frame: 0-72 hours
Area under the plasma concentration versus time curve
AUCτ,ss of Metformin
Time Frame: 0-144 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Secondary Outcomes
- Tmax of DWP 16001, Metformin, DWP16001 Metabolites(0-144 hours)
- T1/2 of DWP 16001, Metformin(0-144 hours)
- fe of DWP 16001, DWP16001 Metabolites(0-72 hours)
- AUC of DWP 16001, Metformin, DWP16001 Metabolites(0-144 hours)
- CL/F of DWP 16001, Metformin(0-144 hours)
- CLR of DWP 16001(0-144 hours)
Investigators
Study Sites (1)
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