None listed
Conditions
Interventions
Drug : Study 1: This is a randomized, open, single dose, 3-sequence, 1-period parallel design study. A total of 12 subjects are randomly assigned to 1 of 3 sequences of the three doses, DA-9701 30 mg,
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A healthy adult who is 19 years old or older at the screening test 2. Body mass index (BMI) greater than 17.5 kg / m2 and less than 30.5 kg / m2 and body weight greater than 55 kg ? Body Mass Index (BMI) = body weight (kg) / height (m) 2 3. Patients who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination 4. A person who has been judged to be suitable for the test subject to be tested at screening such as laboratory tests (hematology test, blood chemistry test, urine test, etc.) and electrocardiogram test conducted according to the characteristics of medicines 5. For women, those who have been confirmed as non-pregnant and have agreed to maintain contraception during the clinical trial 6. Those who signed the written consent of the Institutional Review Board (IRB) of Chonbuk Natioinal University Hospital to participate in this study with full understanding of the purpose and contents of the examination prior to taking the test 7. Those who have the ability and willingness to participate in the test
Exclusion criteria
Exclusion criteria: 1. A person with evidence or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic disease (except for asymptomatic seasonal allergies at the time of administration) 2. Those with a history of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease) or surgery (except for simple cecal surgery or hernia surgery) that can affect the absorption of drugs 3. Those who show the following figures as a result of laboratory tests ? ALT or AST> 2 times upper limit of normal range 4. Screening If you have a regular alcohol intake history of more than 210 g/week within 6 months (10 g of beer (5%) = 10 g, 1 glass of soju (20%) = 8 g , Wine (12%), 1 cup (125 mL) = 12 g) 5. Those who took other clinical trials or bioequivalence testing drugs within 3 months before the first administration of clinical trial drug 6. When the left-sided blood pressure is greater than 140 mmHg (systolic blood pressure) or> 90 mmHg (diastolic blood pressure) 7. Anyone with a history of major alcohol or drug abuse within a year of screening 8. Those who take drugs known to induce or inhibit drug metabolizing enzymes within 30 days before the first administration of clinical trial medication 9. More than 20 smokers per day 10. Those who take prescription or non-prescription drugs within 10 days before the first administration of clinical trial medication 11. Those who take the first blood donation within 2 months before the first administration, or the blood donation within one month before the first administration of clinical trial medication 12. Persons who are at risk of serious adverse/chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and participation in testing, or may interfere with the interpretation of test results 13. Patients with a history of hypersensitivity to the test drug or the components of the test drug 14. Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 15. Those who can not consume the high-fat diet provided in Part 2 of this clinical trial 16. Those who are not willing or able to comply with the guidelines for administering the subjects described in this study plan 17. Anyone deemed to be unfit for participation in this examination, as determined by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast, AUCinf, Cmax of the marker compound of DA-9701 in plasma;Umax, Cumulative Amount Excreted(Ae), Fraction of the dose excreted unchanged(Fe), Renal Clearance(CLR) of the marker compound of DA-9701 in urine;Adverse event, physical examinations, routine laboratory assessments, vital sign measurements and electrocardiogram (ECG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2 etc.of the marker compound of DA-9701 in plasma | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Young Jeon
Chonbuk National University Hospital
Outcome results
None listed