| Eligibility |
Inclusion Criteria:
1. Those who voluntarily decide to participate and agree to comply with the cautions
after fully understand the detailed description of this clinical trial.
2. Healthy adult who aged 19 to 55 years.
3. Those who meet the criteria of anthropometric data
- Man: Body weight = 50 kg, Body mass index 18 to 30 kg/m2
- Woman: Body weight = 45 kg, Body mass index 18 to 30 kg/m2
Exclusion Criteria:
1. Those who have medical history of hypersensitivity to active pharmaceutical ingredient
(Lobeglitazone, Sitagliptin, Metformin) or additives.
2. Those who have clinically significant disease or medical history of Hepatopathy, Renal
dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder,
Genitourinary system disorder, Digestive system disorder, Endocrine system disorder,
Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract
infection.
3. Those who have past medical history of gastrointestinal disorder (Crohn's disease,
ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect
the absorption of drug.
4. Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or
psychotropic drugs such as psychotropic drugs) or persons with a history of substance
abuse.
5. Those who have the test results written below
- AST, ALT > 2 times higher than upper normal level
- Total bilirubin > 2 times higher than upper normal level
- eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60
mL/min/1.73m2
- "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
- Under 3 min resting condition, systolic blood pressure >160 mmHg or <90 mmHg,
diastolic blood pressure >100 mmHg or <50 mmHg
6. Those who have determined that the abnormal results are clinically significant in the
screening test items (question, vital signs, electrocardiogram, physical test, blood,
urine test, etc.).
7. Those who participated in other clinical trials within 180 days of the intended study
drug administration and have been administered clinical trial medications (except for
those who have not taken the study medication).
8. Those who has taken a drug (Ethical drug, over the counter drug, herbal medicine, or
nutritional supplement (vitamin, etc.)) within 14 days prior to first investigational
product administration (however, if it is considered that it does not affect the
safety and research results of the subject, as determined by the investigator).
9. Those who donated whole blood within 8 weeks prior to first investigational product
administration, or who donated or donated components (plasma, platelets) within 4
weeks, and consented to prohibit blood donation from 30 days after the last
administration of investigational product.
10. Those who have continuously consumed more than 21 units/week (1 unit of alcohol = 10 g
= 12.5 mL) within 6 months prior to screening.
11. Those who have more than 10 smokers a day within 6 months prior to screening.
12. Those who cannot use clinically acceptable contraceptive methods (e.g., infertility
surgery between themselves and partners, intrauterine contraceptive devices, use of
diaphragms or condoms) from the time the drug is administered to the last visit.
13. Those who cannot inhibit the diet (especially grapefruit juice, caffeine) that can
affect the absorption, distribution, metabolism, and excretion of the drug from 3 days
before the first administration of the investigational product to the last visit.
14. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency
or glucose-galactose malabsorption.
15. Those who receive intravenous administration of radioactive iodine contrast agents
(for intravenous urography, venous cholangiography, angiography, computed tomography
using contrast agents, etc.) within 48 hours before the first administration of
investigational product.
16. Those who are pregnant or breastfeeding.
17. Those who are deemed inappropriate to participate in clinical trial by investigators.
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