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To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination

Primary Purpose

FDC, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWC202213
DWJ1563
DWP16001
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for FDC

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Chungbuk National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

AUC0-t of DWP16001
AUC0-t of DWP16001
Cmax of DWP16001
Cmax of DWP16001
AUC0-t of DWC202213
AUC0-t of DWC202213
Cmax of DWC202213
Cmax of DWC202213

Secondary Outcome Measures

Full Information

First Posted
January 17, 2023
Last Updated
February 10, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05737771
Brief Title
To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination
Official Title
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of the Fixed-dose Combination of DWJ1563 Compared to the Loose Combination of DWP16001 and DWC202213
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FDC, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
Arm Title
Group B
Arm Type
Other
Arm Description
administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
Intervention Type
Drug
Intervention Name(s)
DWC202213
Intervention Description
DWC202213
Intervention Type
Drug
Intervention Name(s)
DWJ1563
Intervention Description
DWJ1563
Intervention Type
Drug
Intervention Name(s)
DWP16001
Intervention Description
DWP16001
Primary Outcome Measure Information:
Title
AUC0-t of DWP16001
Description
AUC0-t of DWP16001
Time Frame
0 to 24 hours
Title
Cmax of DWP16001
Description
Cmax of DWP16001
Time Frame
0 to 24 hours
Title
AUC0-t of DWC202213
Description
AUC0-t of DWC202213
Time Frame
0 to 24 hours
Title
Cmax of DWC202213
Description
Cmax of DWC202213
Time Frame
0 to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Gi Hwang, MD, PhD
Phone
043 269 8747
Email
jk_hwang@cbnuhctc.com
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Seowon-gu
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun A Lee
Phone
43-269-8618
Email
ha_lee@cbnuhctc.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination

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