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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; FDC
• Intervention / Treatment: Drug: DWC202213; Drug: DWJ1563; Drug: DWP16001

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jun Gi Hwang, MD, PhD; Phone Number: 043 269 8747; Email: jk_hwang@cbnuhctc.com

Study Locations

• Korea, Republic of
  • Seowon-gu
    • Cheongju-si, Seowon-gu, Korea, Republic of, 28644
      • Recruiting
      • Chungbuk National University Hospital
      • Contact: Hyun A Lee; Phone Number: 43-269-8618; Email: ha_lee@cbnuhctc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period	Drug: DWC202213; DWC202213; Drug: DWJ1563; DWJ1563; Drug: DWP16001; DWP16001
Other: Group B; administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period	Drug: DWC202213; DWC202213; Drug: DWJ1563; DWJ1563; Drug: DWP16001; DWP16001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Estimate): February 21, 2023

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_DWJ1563101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No