| Eligibility |
Inclusion Criteria:
- Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass
index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
- Those who agree to rule out the possibility of their and their spouses' or sexual
partners' pregnancy by using methods of contraception (In the case of a female
subject, hormone drugs is excluded) accepted in clinical trial from the date of the
first administration of the investigational products to 7 days after the last
administration and disagrees to provide their sperm or ovum.
*Methods of contraception accepted in clinical trial: Combined use of intrauterine
device, vasectomy, tubal ligation, and barrier methods (male condom, female condom,
cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods
if spermicide is used.
- Those who sign written consent spontaneously after listening to and understanding
sufficient explanation of the purpose and contents of this clinical trial,
characteristics of the Investigational products, expected adverse events, etc.
Exclusion Criteria:
- Those who have clinically significant diseases or past history of the gastrointestinal
system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic
disease, infectious disease, kidney
& genitourinary system, neuropsychiatric system, musculoskeletal system, immune
system, ENT system, skin system, ophthalmic system.
- Those who have a medical history of gastrointestinal surgery (Except for simple
appendectomy, hernia surgery) or gastrointestinal diseases that may affect the
absorption of drugs.
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as
barbiturate within 1 month prior to the first day of administration or have taken ETC,
OTC, herbal medicine and health functional foods concerned about affecting this
clinical trial within 10 days prior to the first day of administration. (however,
participation is possible considering pharmacokinetics and pharmacodynamics such as
Interaction of investigational products, half-life of concomitant drugs)
- Those who have participated in other clinical trials or bioequivalence tests and
administered their investigational products within 6 months prior to the first
administration date.
- In the case of a female subject, those suspected pregnancy, pregnant woman, lactating
woman.
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