| Eligibility |
Inclusion Criteria:
1. A healthy adult between 19 and 50 years of age at the time of screening 2. Koreans,
Caucasian, and Hispanics are classified according to the following criteria.
1. Korean: A Korean ethnic group born in Korea or outside Korea who has lived abroad for
10 years and has Korean parents and grandparents.
2. Caucasian: Born in Europe, living abroad in Europe for 10 years, Europeans with
European parents and grandparents
3. Hispanic: Subjects of Latin American races with parents and grandparents who are Latin
American, having nationalities from Mexico, Puerto Rico, Cuba, Latin America, or other
Spanish cultures.
3. At the time of screening test, if the weight is more than 50.0 kg or less than 90.0 kg,
the body mass index (BMI) is 18.0 kg/m^2 or more 30.0 kg/m^2 or less (*body mass index, kg
/m^2) = weight (kg) / [height (m)] 2) 4. In the case of female volunteers, factors such as
not necessarily pregnant or lactating or surgical infertility (both difficulty tube
closure, hysterectomy, both difficulty tube resection, both ovarian resection, etc.) 5. A
person who has heard sufficient explanation of this clinical trial and fully understood it,
voluntarily decided to participate, and agreed in writing to comply with precautions.
Exclusion Criteria:
1. Clinically significant hepatometer (severe liver disorder, etc.), kidney (severe renal
disorder, etc.), nervous system, immune system, respiratory system, digestive system,
endocrine system, blood • tumor, cardiovascular system (heart failure, Torsades de
points, etc.), urinary system, mental system, etc.
2. A person who has a history of hypersensitivity or clinically significant
hypersensitivity to DWP16001 and other drugs (aspirin, antibiotics, etc.), including
homogeneous drugs.
3. Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis,
stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery
that may affect the safety and pharmacokinetic/pharmacodynamic evaluation of DWP16001
(however, simple appendicectomy, excluding hernia surgery)
4. The person who showed the following results in the screening test. 1) Blood AST
(SGOT), ALT (SGPT):> Upper limit of normal range × 1.5 2) Creatine cleaning rate
calculated through MDRD equation: <90 mL/min 3) Serum glucose on an empty stomach:
>110 mg/dL or <70 mg/dL 4) Serum test (syphilis test, hepatitis B test, hepatitis C
test, human immunodeficiency virus (HIV) test) results are positive factors.
5. Those with a systolic blood pressure <90 mmHg or >150 mmHg or diastolic blood pressure
<60 mmHg or >100 mmHg in vital signs measured in the sitting position after resting
for more than 3 minutes
6. Those who have a history of drug abuse or who have tested positive for drugs of abuse
in urine screening tests
7. Those who have taken any prescription drugs or herbal medicines within 2 weeks before
the expected first dose, or have taken any over-the-counter (OTC) drugs, health
functional foods, or vitamins within 1 week (however, different conditions according
to the judgment of the researcher) In this reasonable case, you can participate in the
clinical trial) or those who are expected to take it
8. Those who have taken drugs that induce or inhibit drug metabolizing enzymes, such as
barbiturates, within 1 month before the expected first administration date
9. A person who participated in other clinical trials (including biological equivalence
tests) and administered drugs for clinical trials within 6 months of the expected
first dose date.
10. A person who donated whole blood within 2 months prior to the expected first dose or
donated ingredients within 1 month prior to the expected first dose date, or received
a blood transfusion within 1 month prior to the expected first dose date.
11. A person who is unable to drink continuously (exceeds 21 units/week, 1 unit = 10 g of
pure alcohol) or to abstain from drinking during the period from 3 days before the
expected first administration date to the last discharge.
12. A current smoker (however, if he/she quit smoking three months before the expected
first dose date, he/she can be selected as a test subject) or a person who cannot stop
smoking during the period from the time of discharge.
13. Those who cannot refrain from eating grapefruit (grapefruit)-containing food during
the period from 3 days before the expected first administration date to the last
discharge
14. A person who continuously consumed excessive caffeine (> 5 units/day) or who cannot
prohibit the intake of caffeine/caffeine-containing foods (coffee, tea (black tea,
green tea, etc.), soda, coffee milk, nutritional tonic drinks, etc.) during the
expected first 3 days to the last discharge.
15. Those who cannot use an appropriate double contraceptive method or medically
acceptable method of contraception for themselves, their spouse, or their partner
during the entire clinical trial period, and those who do not agree not to donate
sperm or eggs until the relevant period
- Medically acceptable contraceptive method
1. The use of intrauterine devices with proven pregnancy failure rates in
oneself or spouse (or partner)
2. Use of both blocking contraception method (for men or women) and skin killer
at the same time.
3. Surgery of the person or partner (vascularization, arthroplasty/ligation,
hysterectomy
16. Those who do not meet the above selection criteria or who are judged by the researcher
as unsuitable to participate in the clinical trial due to reasons other than those
that fall under the exclusion criteria
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