| Eligibility |
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 Bundang Cha 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 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:
1. 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.
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, endoscopic polyp surgery, hemorrhoids, hemorrhoids, hemorrhoids,
and healing surgery).
3. 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)
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)
- 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.
5. 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).
6. 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.)
7. Those who took other clinical trial drugs within 180 days before the first scheduled
date of administration of clinical trial drugs (however, the criteria for termination
of participation in previous clinical trials are calculated as one day based on the
last administration date.)
8. A person who has continuously consumed more than 21 units/week (1 unit = 10g = 12.5
mL) within 6 months of screening or cannot abstain from drinking alcohol from 3 days
before the first administration of clinical trial drugs to the last visit.
? Alcohol amount (g) = Consumption (mL) x frequency (%) x 0.8
9. Those who smoke more than 10 cigarettes a day within 6 months of screening and who
cannot quit smoking excessively from 3 days before the first clinical trial drug
administration to the last visit or quit smoking from the date of hospitalization to
the last blood collection.
10. A person who donated whole blood within 8 weeks before the first scheduled date of
administration of clinical trial drugs, or who donated whole blood within 4 weeks
(plasma, platelet), or did not agree to prohibit blood donation until 30 days after
the last administration date.
11. Those who did not agree to stop taking diet (e.g., grapefruit) that could affect the
absorption, distribution, metabolism, and excretion of drugs from three days before
the first administration of clinical trial drugs to the last blood collection.
12. Those who do not agree to consume excessive caffeine (400 mg/day) from 3 days before
the first clinical trial drug administration to the last visit or to stop consuming
caffeine-containing foods from the date of hospitalization to the time of blood
collection.
13. A person who does not use the appropriate contraceptive method recognized by his/her
spouse or partner from the time of written consent to the subject until two weeks
after the date of administration of the last clinical trial drug.
14. Pregnant women or lactating women identified during screening.
15. Other persons who have judged that they are inappropriate to participate in this
examination as judged by the tester.
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