Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04343547

Enrollment

Registered

2020-04-13

Start date

2020-04-30

Completion date

2020-07-31

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.

Interventions

DRUGDWP16001

Tablets, Oral, once daily single dose

DRUGDWC202001+DWC202002

Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination

DRUGDWP16001+DWC202001+DWC202002

Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure 2. 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0 3. Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information 4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion criteria

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder 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 gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug. 3. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.) 4. Considered ineligible for the study by the investigator for reasons including laboratory test results

Design outcomes

Primary

Measure	Time frame	Description
Cmax of DWP16001	0-72 hours	Peak Plasma Concetration
AUClast of DWP16001	0-72 hours	Area under the plasma concentration versus time curve
Cmax,ss of DWC202001 and DWC202002	0-72 hours	Peak Plasma Concetration at steady-state
AUCτ,ss of DWC202001 and DWC202002	0-72 hours	Area under the plasma concentration versus time curve at Tau, steady-state

Secondary

Measure	Time frame	Description
T1/2 of DWP 16001, DWC202001 and DWC202002	0-72 hours	—
CL/F of DWC202001 and DWC202002	0-72 hours	—
Tmax of DWP 16001, DWC202001 and DWC202002	0-72 hours	Time at Cmax

Countries

South Korea

Contacts

Primary ContactJin Hyun Choi

jhchoi413@daewoong.co.kr82-02-550-8406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026