A randomized, open-label, single dose, 2-way crossover study to evaluate the pharmacokinetic characteristics of EL-1401 in comparison to the co-administration of nebivolol and rosuvastatin in healthy volunteers
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002283
- Lead Sponsor
- Elyson Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
(1) Healthy adult subject’s who is at least 19 years and under 55 years at screening
(2) BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 45kg
(3) Subject who don't have congenital or chronic diseases and have no abnormal medical examination results withn 3 years
(4) Suitable subject who is determined by ECG and laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug at screening.
(5) Subjects 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 Chonbuk National University Hospital IRB.
(6) Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
(1) Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
(2) Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
(3) Subjects who show alanine transferase or aspartate aminotransferase >2 times upper limit of normal range.
(4) Subjects who drink Alcohol> 210g/week within 6 months prior to the screening. (1 glass(250ml) of Beer(5%) = 10g, 1 glass(50ml) of Soju(20%)= 8g, 1 glass(125ml) of Wine(12%)= 12g)
(5) Subjects who take the medication involved in other clinical trials or bioequivalence test within three months before the first dose medication characters.
(6) Subjects who show hypotension (Systolic Blood Pressure < 90mmHg), hypertension (SBP >140mmHg) or Diastolic Blood Pressure > 90 mmHg at screening.
(7) Subjects who have history of alcohol or drug abuse, within 1year.
(8) Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
(9) Smoker (=20 cigarettes/day)
(10) Subjects who takes ethical the count or over the count medicine within 10days before the first investigational product administration.
(11) Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
(12) Subjects who can increase risk due to clinical test and administration of drugs or have severe grade/ chronic medical, mental condition or abnormal laboratory test it that may interfere with the analysis of test results.
(13) Patients with hypersensitivity to the components of investigational drug.
(14) Patients with bronchospasm or asthma.
(15) Patients with metabolic acidosis.
(16) Patients with bradycardia (< 50 bpm) and atrioventricular block (2?and 3?).
(17) Patients with acute heart failure, cardiogenic shock or decompensated heart failure in need of inotropic treatment (intravenous).
(18) Patients with uncontrolled heart failure.
(19) Patients with severe peripheral circulatory disorders.
(20) Patients with sinus node dysfunction syndrome, including sinoatrial block.
(21) Patients with untreated pheochromocytoma.
(22) Patients with hepatic failure or liver function impairment.
(23) Patients with severe renal impairment of renal failure.
(24) Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
(25) Patients with myopathy.
(26) Patients who concomitantly administrated cyclosporine.
(27) Pregnant and lactating women, women who do not use appropriate methods of contraception.
(28) Subjects who are not able to comply with guidelines described in the protocol.
(29) Subjects who is determined by investigator’s decision as unsuitable for clinical trial participation.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast, Cmax
- Secondary Outcome Measures
Name Time Method AUCinf