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

NCT ID: NCT05737771

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-06-30

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.

Conditions

FDC; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: OTHER

DWC202213

Intervention Type: DRUG

DWC202213

DWJ1563

Intervention Type: DRUG

DWJ1563

DWP16001

Intervention Type: DRUG

DWP16001

Group B

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

Group Type: OTHER

DWC202213

Intervention Type: DRUG

DWC202213

DWJ1563

Intervention Type: DRUG

DWJ1563

DWP16001

Intervention Type: DRUG

DWP16001

Interventions

DWC202213

DWC202213

Intervention Type: DRUG

DWJ1563

DWJ1563

Intervention Type: DRUG

DWP16001

DWP16001

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungbuk National University Hospital

Cheongju-si, Seowon-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jun Gi Hwang, MD, PhD

Role: CONTACT

jk_hwang@cbnuhctc.com

043 269 8747

Facility Contacts

Hyun A Lee

Role: primary

ha_lee@cbnuhctc.com

43-269-8618

Other Identifiers

DW_DWJ1563101

Identifier Type: -

Identifier Source: org_study_id