A Crossover, Randomized, Open-label, Comparison Study Between DWJ1525 and the Concomitant Use of DWP16001 and DWC202101 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- DWC202101
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- AUClast
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Four-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of DWJ1525 and the Co-administration of DWP16001 and DWC202101 for Healthy Subjects in Fed and Fasted State
Detailed Description
A single dose of the test (T) and two of the reference (R) products will be administered to the study subjects, according to a randomized, open-label, single oral dosing, two-sequence, and four-period crossover for healthy subjects in fed and fasted state study design. A wash-out interval of at least 7 days will elapse between the each administrations. The three investigational products will be administered with 150 mL of still mineral water on day 1 of the four study periods.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Bundang Cha Hospital to participate in this study according to his free will.
- •Healthy adults aged 19 or older at the time of screening.
- •Those who weigh more than 50 kg in men, weigh more than 45 kg in 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
- •A person with a clinically significant history in liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, blood and tumor system, cardiovascular system (including orthostatic hypotension), etc.
- •A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia, endoscopic polyp surgery, hemorrhoids, hemorrhoids, hemorrhoids, and healing surgery).
- •Those who are hypersensitive to other drugs (aspirin, antibiotics, etc.) or have a history of clinically significant hypersensitivity reactions, including clinical drug ingredients (Enavogliflozin, Metformin) and homogeneous (SGLT2 inhibitors)
- •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)
- •If the blood glucose level is greater than 125 mg/dL or less than 60 mg/dL,
- •After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<50 mmHg in vital signs measured at the seat.
- •A person whose abnormal results were judged to be clinically significant in screening test items (examination, vital signs, electrocardiogram, physical examination, blood, urinary examination, etc.) other than those mentioned in paragraph 4).
- •Drugs that do not affect the safety and research results of the subject may be available within 14 days of the first administration of clinical trial drugs (including herbal medicines), general medicines (including vitamins), and health functional foods.)
Arms & Interventions
Group B
fed state: period 1) DWP16001 and DWC2021011, period 2) DWJ15251 fased state: period 3) DWP16001 and DWC2021011, period 4) DWJ15251
Intervention: DWC202101
Group A
fed state: period 1) DWJ15251, period 2) DWP16001 and DWC2021011 fased state: period 3) DWJ15251, period 4) DWP16001 and DWC2021011
Intervention: DWJ1525
Group A
fed state: period 1) DWJ15251, period 2) DWP16001 and DWC2021011 fased state: period 3) DWJ15251, period 4) DWP16001 and DWC2021011
Intervention: DWP16001
Group A
fed state: period 1) DWJ15251, period 2) DWP16001 and DWC2021011 fased state: period 3) DWJ15251, period 4) DWP16001 and DWC2021011
Intervention: DWC202101
Group B
fed state: period 1) DWP16001 and DWC2021011, period 2) DWJ15251 fased state: period 3) DWP16001 and DWC2021011, period 4) DWJ15251
Intervention: DWJ1525
Group B
fed state: period 1) DWP16001 and DWC2021011, period 2) DWJ15251 fased state: period 3) DWP16001 and DWC2021011, period 4) DWJ15251
Intervention: DWP16001
Outcomes
Primary Outcomes
AUClast
Time Frame: At pre-dose (0) and 0.25 to 72 hours post dose
AUClast of plasma DWP16001 and DWC202101
Cmax
Time Frame: At pre-dose (0) and 0.25 to 72 hours post dose
Cmax of plasma DWP16001 and DWC202101