KCT0002482
Completed
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
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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