NCT05737771

Brief Summary

To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

January 17, 2023

Last Update Submit

February 10, 2023

Conditions

FDCDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • AUC0-t of DWP16001

    AUC0-t of DWP16001

    0 to 24 hours

  • Cmax of DWP16001

    Cmax of DWP16001

    0 to 24 hours

  • AUC0-t of DWC202213

    AUC0-t of DWC202213

    0 to 24 hours

  • Cmax of DWC202213

    Cmax of DWC202213

    0 to 24 hours

Study Arms (2)

Group A

OTHER

administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period

Drug: DWC202213Drug: DWJ1563Drug: DWP16001

Group B

OTHER

administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period

Drug: DWC202213Drug: DWJ1563Drug: DWP16001

Interventions

DWC202213DRUG

DWC202213

Group AGroup B
DWJ1563DRUG

DWJ1563

Group AGroup B
DWP16001DRUG

DWP16001

Group AGroup B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Chungbuk University Hospital to participate in this study according to his free will.
  • Healthy adults aged 19 or older at the time of screening.
  • Those who weigh more than 50.0 kg in men and women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women.
  • Body mass index (BMI) = Weight (kg) / \[Height (m)\] 2.

You may not qualify if:

  • A person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc.
  • A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia).
  • Those who are hypersensitive to other drugs (DPP-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including DWP16001, DWC202213 and homogeneous (SGLT2 inhibitors)
  • A person who shows the following results in the inspection items conducted during screening.
  • Blood ALT, AST, Total bilirubin \> twice the upper limit of the normal range.
  • The glomerular filtration rate (e-GFR) \<90 mL/min/1.73 m2 (using the CKD-EPI method)
  • After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<60 mmHg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, Seowon-gu, 28644, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jun Gi Hwang, MD, PhD

CONTACT

043 269 8747jk_hwang@cbnuhctc.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 21, 2023

Study Start

January 25, 2023

Primary Completion

March 31, 2023

Study Completion

June 30, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

KR(1)