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

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: FDC; Diabetes Mellitus, Type 2

Treatments: Drug: DWC202213; Drug: DWP16001; Drug: DWJ1563

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737771

DW_DWJ1563101

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Other group

Description:

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

Treatment:

Drug: DWC202213

Drug: DWJ1563

Drug: DWP16001

Group B

Other group

Description:

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

Treatment:

Drug: DWC202213

Drug: DWJ1563

Drug: DWP16001