KCT0002482已完成未知
A randomized, open-label, single dose, phase 1 study to evaluate the safety, tolerability, food effect, and pharmacokinetic characteristics of DA-9701 in healthy volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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