KCT0001794Completed未知
A randomized, open-label, multiple dosing, crossover study to evaluate the pharmacokinetic drug-drug interaction and safety between nebivolol and rosuvastatin in healthy male volunteers
Elyson Pharmaceutical0 sites44 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- Male
Inclusion Criteria
- •(1)Healthy male subject’s age =19 years at screening
- •(2)BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- •(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.
Exclusion Criteria
- •(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)Subjects who are not able to comply with guidelines described in the protocol.
- •(28)Subjects who is determined by investigator’s decision as unsuitable for clinical trial participation.
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A randomized, open-label, multiple doses, crossover study to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapyKCT0001067Chong Kun Dang24
Recruiting
Not Applicable
A randomized, open-label, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of EL-1804 and co-administration of EL-1804R-1 and EL-1804R-2 in healthy adult subjectsKCT0006661Elyson Pharmaceutical40
Completed
Not Applicable
A randomized, open-label, multiple doses, crossover study to evaluate a pharmacokinetic drug interaction and safety of Candesartan free combination of Candesartan and Amlodipine and Candesartan monotherapyKCT0001052Chong Kun Dang24
Recruiting
Not Applicable
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male VolunteersKCT0000176Yonsei University Health System, Severance Hospital36
Completed
Not Applicable
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic AlopeciaDiseases of the skin and subcutaneous tissueKCT0001989Dong-A ST14