| Eligibility |
Inclusion Criteria:
1. Those who are 19 years old or older at the time of the screening visit
2. At the time of screening visit, those who weigh 50 kg or more for men, 45 kg or more
for women, and have a body mass index (BMI) of 18.0 kg / m2 or more and 30.0 kg / m2
or less.
? BMI (kg / m2) = Weight (kg) / {Height (m)} 2
3. Those who have no clinically significant congenital or chronic illness at the time of
the screening visit and have no medical examination results, pathological symptoms or
findings.
4. Diagnostic tests such as hematology tests, blood chemistry tests, serum tests, urine
tests, and electrocardiogram test result tests set and performed by the test director
(or the commissioned doctor in charge of the test) according to the characteristics of
the clinical test drug. Now that it has been determined to fit the subject
5. Clinical trial drug From the first dosing date to the last clinical trial drug 14 days
from the dosing date, the person, sperm, or partner should use medically appropriate
contraceptive methods * to eliminate the possibility of pregnancy. Agree and agree not
to donate sperm or eggs
* Contraceptives: Combined use or killing of intrauterine devices, sperm surgery,
tubal contraception and blockage contraceptives (male condoms, female condoms,
cervical caps, contraceptive diaphragms, sponges, etc.) When using spermicide, use two
or more contraceptive methods as a combination
6. A person who has signed a consent form by a free doctor after listening to and
understanding the purpose and content of this clinical trial, the characteristics of
the drug for clinical trial, expected abnormal reactions, etc.
Exclusion Criteria:
1. Digestive system, cardiovascular system, endocrine system, respiratory system, blood /
tumor, infectious disease, kidney and urogenital system, psychiatric / nervous system,
musculoskeletal system, immune system, otolaryngology, dermatology, ophthalmology
People with clinically significant illness or past strength who fall into the system
2. Those who have past ability of gastrointestinal surgery (excluding simple appendectomy
and hernia surgery) that can affect drug absorption, or have gastrointestinal illness
3. Those who took drug-metabolizing enzyme-inducing and inhibitory drugs such as barbital
drugs within 1 month of the first dosing date, or took drugs that may interfere with
this clinical study within 10 days of the first dosing date (however) , Interaction
with clinical study drugs, half-life of concomitant drugs, etc. Can be participated in
consideration of drug dynamics and pharmacodynamics)
4. Those who participated in other clinical trials or bioequivalence studies and received
clinical trial drugs within 6 months of the first dosing date.
5. Those who donated whole blood or component blood within 2 weeks or received blood
transfusion within 4 weeks on the first dosing day
6. Those who meet the following conditions within one month of the first dosing date
- For men, alcohol intake exceeding 21 cups / week on average
- For females, alcohol intake exceeding 14 cups / week on average
(1 cup = 50 mL of shochu or 30 mL of Western liquor or 250 mL of beer)
- Smoking an average of 20 cigarettes or more per day
7. Those who fall under the following
· Persons with hypersensitivity to the main ingredients or constituents of this drug
• Persons with genetic problems such as galactose intolerance, Lapp lactase deficiency
or glucose-galactose malabsorption
8. Patients with the following diseases
- Patients with active liver disease or patients with persistently high symptoms
due to unknown causes of serum amino transduction enzyme levels
- Patients with muscle disease
- Patients receiving cyclosporine in combination
- Patients with moderate renal disorder or severe renal failure (eGFR <60 ml / min
/ 1.73 m2)
- Patients who are susceptible to myopathy and rhabdomyolysis
- Patients with hypothyroidism
- Patients with a history of genetic muscle disease or family history
-Patients with a history of muscle toxicity to statins (HMG-CoA convertase
inhibitors) or fibrates
- Alcoholics
- Patients treated with fibrates
9. Persons who are judged by the investigator (or the commissioned investigator) to be
unsuitable for participation in this clinical study due to reasons other than the
above selection / exclusion criteria.
10. In the case of female applicants, pregnant women or those who are suspected of
becoming pregnant or breastfeeding
|
