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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05737771
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
5.1
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 25, 2023
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. AUC0-t of DWP16001 [0 to 24 hours]

    AUC0-t of DWP16001

  2. Cmax of DWP16001 [0 to 24 hours]

    Cmax of DWP16001

  3. AUC0-t of DWC202213 [0 to 24 hours]

    AUC0-t of DWC202213

  4. Cmax of DWC202213 [0 to 24 hours]

    Cmax of DWC202213

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chungbuk National University Hospital Cheongju-si Seowon-gu Korea, Republic of 28644

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT05737771
Other Study ID Numbers:
  • DW_DWJ1563101
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 21, 2023