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

Phase 1

Recruiting

• Conditions: FDC; Diabetes Mellitus, Type 2
• Interventions: Drug: DWC202213; Drug: DWJ1563; Drug: DWP16001

• Registration Number: NCT05737771
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-17
• Study Start: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-10
• Last Update Submitted: 2023-02-10
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	DWP16001	administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
Group B	DWC202213	administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
Group A	DWP16001	administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
Group B	DWJ1563	administrate DWJ1563 at first period, and administrate DWP16001 + DWC202213 at second period
Group A	DWC202213	administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period
Group A	DWJ1563	administrate DWP16001 + DWC202213 at first period, and administrate DWJ1563 at second period

Primary Outcome Measures

Name	Time	Method
AUC0-t of DWC202213	0 to 24 hours	AUC0-t of DWC202213
Cmax of DWP16001	0 to 24 hours	Cmax of DWP16001
Cmax of DWC202213	0 to 24 hours	Cmax of DWC202213
AUC0-t of DWP16001	0 to 24 hours	AUC0-t of DWP16001

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Seowon-gu, Korea, Republic of