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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737771
• Other study ID #: DW_DWJ1563101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 25, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Jun Gi Hwang, MD, PhD
• Phone: 043 269 8747
• Email: jk_hwang[@]cbnuhctc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Healthy adults aged 19 or older at the time of screening.

3. 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:

1. 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.

2. A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia).

3. 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)

4. 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)

5. 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• DWC202213
DWC202213
• DWJ1563
DWJ1563
• DWP16001
DWP16001

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Seowon-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t of DWP16001	AUC0-t of DWP16001	0 to 24 hours
Primary	Cmax of DWP16001	Cmax of DWP16001	0 to 24 hours
Primary	AUC0-t of DWC202213	AUC0-t of DWC202213	0 to 24 hours
Primary	Cmax of DWC202213	Cmax of DWC202213	0 to 24 hours