None listed
Conditions
Interventions
Drug : • Target number of subjects : 48 subjects
• Study design : 2x4 Cross-over
• Test group : KD5001 1 tablet, Exforge/Crestor 1 tablet
• Reference group : KD5001 1 tablet, Exforge/Crestor 1 tablet
Sponsors
Kyung Dong Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) ???? ?? ?? ??? ? 19? ?? ??? ?? 2) Those who have a body mass index (BMI) of 18.5 kg / m2 to 27.0 kg / m2 at screening 3) Patients with no congenital or chronic disease and no medically symptomatic findings 4) Those who have been determined to be eligible as a result of clinical tests and electrocardiogram tests, such as serum tests, hematology tests, blood chemistry tests, and urine tests, which were performed by the doctor in charge within 4 weeks prior to administration of the clinical trial drug 5) After fully hearing and understanding the details of this clinical trial, you agree to voluntarily decide to participate and to comply with the Notice
Exclusion criteria
Exclusion criteria: 1) Persons who have a history of hypersensitivity reactions or other clinically significant hypersensitivity to other drugs or additives in the main components or components of clinical trial medicines 2) Persons with a history of drug absorption, distribution, metabolism, and excretion 3) Patients with hereditary angioedema or with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists 4) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 5) If there is a history or family history of genetic myopathy 6) ?? HMG-CoA ???? ??? ?? ?????? ?? ?? ??? ??? ?? ?? 7) In patients with vital signs, the left systolic blood pressure = 140 mmHg or 10 cfu / day) who are unable to abstain during the clinical trial from 3 days prior to the clinical trial, or those who are unable to continue drinking during the trial (21units / week, 1unit = 10g = 12.5mL of pure alcohol) 13) From the screening date until 30 days after the last clinical trial drug administration, appropriate double-pregnancy or medically acceptable contraceptive methods (including intrauterine devices with proven pregnancy failure rates, physical contraceptive methods and spermicide) Use, vasectomy, tubal resection / ligation, hysterectomy, etc.) 14) Women who are pregnant or who may be pregnant and breastfeeding 15) Any person taking any OTC medicines or herbal medicines within 2 weeks of the first day of medication or who has taken any OTC medication within 1 week will be subject to the judgment of the examiner that the medication will affect the test or the safety of the subject When it is judged to be influential 16) Those who have participated in other clinical studies within 6 months before the first administration day 17) Those who donated whole blood within 2 months before the first administration day, or those who donated blood within 1 month 18) Those who have had abnormal diets that can affect the absorption, distribution, metabolism and excretion of the drug (eg, take 1 mg or more of the grapefruit juice daily within 7 days prior to administration of the clinical trial drug) 19) Serum test (HBsAg, HCV Ab, HIV Ag / Ab, VDRL) Result positive 20) Those who are judged to be ineligible for participation in clinical trials at the discretion of the examiner and the examiner (doctor in charge)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From 0 h to the last quantifiable concentration Area under the concentration-time curve, peak serum concentration;The area under the concentration-time curve from time 0 to infinity, Cmax arrival time | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2, CL/F | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungRan Yoon
Kyungpook National University
Outcome results
None listed