A randomized, open-label, single dose, crossover clinical study to investigate the effect of food on the pharmacokinetics of EL-1804 in healthy adult subjects
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006897
- Lead Sponsor
- Elyson Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1) Healthy adult subject`s age 19~55 years at screening
2) BMI 18.0~29.0kg/m2 and weight more than 50kg
3) Subject who don`t have congenital or chronic disease and have no abnormal medical examination results
4) Suitable subject who is determined by ECG and laboratory test
5) Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by IRB
1) Subjects who have clinically significant or a history of cardiovascular, respiratory, hepatic, kidneys, neurological, endocrine, blood, psychiatric or urinary disease
2) Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
3) Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
4) Subjects with a history of hypersensitivity or clinically significant hypersensitivity to drugs containing the active ingredients or components of the IP or other drugs such as aspirin, antibiotics, etc.
5) Subjects who show hypotension(SBP<90mmHg) or hypertension(SBP>150mmHg or DBP>95mmHg) at the screening
6) Subjects with following results;
- AST or ALT > 2 times upper limit of normal range
- Total bilirubin > 2.0mg/dL
- eGFR < 60mL/min<1.73m2
7) Subjects who drink continually (more than 21units/wee, 1unit=10g=12.5mL of per alcohol) or who can`t drink during the clinical trial period
8) Subjects who continue to smoke (more than 10 cigaratte/day) or who can`t smoke during the hospitalization for the clinical trial period
9) Subjects who take the medication involved in other clinical trials or bio-equivalence study within 6 months before the first administration day
10) subjects who have donated whole blood within 60 days, or a component blood donation within 30 days or received blood transfusion within 30 days before the first administration day
11) Subjects who have taken any prescription or herbal medicine within 14 days or any OTC within 7 days before the first administration day
12) Subjects who have taken drug metabolizing enzyme-inducing and suppressing drugs such as barbital drugs within 1 month before first administration day
13) Subjects who have a diet (particularly grapefruit juice or its products) within 7 days prior to the first administration day that may affect the absorption, distribution, metabolism and excretion of the drug
14) Subjects who don`t agree to exclude the possibility of pregnancy using a medically recognized contraceptive method from the first administration day to 7 days after the last administration of the IP
15) A metal patient, and a drug addict
16) Subjects who are unwilling or unable to comply to diet and lifestyle required in the clinical trail
17) Subjects who have clinically significant abnormalities as a result of other clinical laboratory tests or who edged the person in charge of clinical trail to be ineligible for participation in the clinical trail due to other reason such as non-compliance of instruction, uncooperative attitude, and others
18) Positive finding in pregnant or serum/urine hCG test, or lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC;Cmax
- Secondary Outcome Measures
Name Time Method Vd/Fss;CL/Fss