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CompletedNCT04064073Updated Jan 13, 2020

Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

A Phase 1 interventional study of DWP16001 and Metformin IR in Healthy, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    1

    Drug: DWP16001

  • Experimental
    2

    Drug: Metformin IR

  • Experimental
    3

    Drug: DWP16001+Metformin IR

Interventions

  • DrugDWP16001

    Tablets, Oral, once daily single dose

  • DrugMetformin IR

    Metformin IR 1000mg, Tablets, Oral, BID for 7 days

  • DrugDWP16001+Metformin IR

    Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg

06

What researchers measure

Primary outcomes

  1. Cmax of DWP16001

    Peak Plasma Concetration

    Time frame: 0-72 hours

  2. AUClast of DWP16001

    Area under the plasma concentration versus time curve

    Time frame: 0-72 hours

  3. Cmax,ss of Metformin

    Peak Plasma Concetration at steady-state

    Time frame: 0-144 hours

  4. AUCτ,ss of Metformin

    Area under the plasma concentration versus time curve at Tau, steady-state

    Time frame: 0-144 hours

Secondary outcomes

  1. Tmax of DWP 16001, Metformin, DWP16001 Metabolites

    Time at Cmax

    Time frame: 0-144 hours

  2. AUC of DWP 16001, Metformin, DWP16001 Metabolites

    Area under the plasma concentration versus time curve

    Time frame: 0-144 hours

  3. T1/2 of DWP 16001, Metformin

    Time frame: 0-144 hours

  4. CL/F of DWP 16001, Metformin

    Apparent total clearance of the drug from plasma after oral administration

    Time frame: 0-144 hours

  5. fe of DWP 16001, DWP16001 Metabolites

    Fraction of the drug excreted into the urine

    Time frame: 0-72 hours

  6. CLR of DWP 16001

    Renal clearance of the drug from plasma

    Time frame: 0-144 hours

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04064073
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Aug 14, 2019
Primary completion
Nov 20, 2019
Completion
Nov 20, 2019
Last update
Jan 13, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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