None listed
Conditions
Interventions
Drug : Randomized, Open label, Single dose, 2Treatment, 2way, 2period Crossover Study
-Part A: At 1period, oral administration of RE complex(20/10mg), At 2period, oral co-administration of rosuvastati
Sponsors
Ildong pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Healthy male Korean subject age 20 to 45 at the screening visit 2)Subject who is over 55kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20%(Appendix 2) 3)Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination, subject who is no pathological symptoms or findings. 4)As a results of on the basis of this protocol clinical laboratory test included hematologic examination, blood chemistry test, urine test, urine microscopy, serology test, and ECG, chest X-ray examination, subject who is suitable and involved in clinical trial (If the laboratory medicine test value is within lowered or pass the range of Inha University Hospital, It is determined that there is no clinically significant from Principle Investigator. 5)After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
Exclusion criteria
Exclusion criteria: 1)Subject who has history or presence of clinically significant disease in liver, pancreas, kidney, nervous system, respiratory system, endocrine system, blood•tumor, mental illness, cardiovascular system and urinary system. 2)Subject who has history of presence of gastrointestinal diseases(gastro-intestinal tract ulcer, stomach cramp, gastroesophageal reflux disease and Crohn's disease and so on.) that can affect the absorption of investigational product and has history of gastrointestinal surgery(except for cecum surgery and hernia surgery) 3)Subject who is hypersensitive to medicine containing component of rosuvastatin, ezetimibe or other medicine(asprin, antibiotics and so on.) 4)Subject who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5)In laboratory tests, the subject who shows the results that fall into any of the following -Aspartate Aminotransferase or Alanine Aminotransferase > above 1.5times of normal range -Total bilirubin > above 1.5times of normal range 6)Subject who has low blood pressure(systolic pressure: under 100mmHg or diastolic blood pressure: under 55mmHg) or hypertension(systolic pressure: over 150mmHg or diastolic blood pressure: over 95mmHg) or exceed the heart rate 100times 7)Subject who has medical history of use of durgs of abuse 8)Subject who takes the medicine of drug metabolizing enzyme revulsant and depressant of barbital drugs within 4weeks before the first administration 9)Subject who takes some ethical drug or herbal medicine within 2weeks or some Over The Counter within 1week before the first administration (Based on the investigator's judgment, if other conditions are appropriate, it is possible to participate in clinical trials) 10)Subject who takes grapefruit or the fruit product within 1week before the first administration 11)Subject who takes investigational product of other clinical study within 3months before the frist administration. 12)Subject who takes whole blood donation within 2months or apheresis within 1month before the first administration 13)Subject who drinks consistently (above 21 units/week, 1unit=10g of pure alcohol) and can't stop drinking during the treatment period 14)Subject who smokes consistently (above 10cigarettes/day)and can't stop smoking during the treatment period 15)As the results of clinical laboratory test included other reasons, subjects who is determined to be unsuitable about participation in clinical trial 16)Subject who is unable to contraception during the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt and Cmax of Rosuvastin ;AUCt and Cmax of Ezetimibe | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, T1/2 and AUC8 of Rosuvastatin;Tmax, T1/2 and AUC8 of Ezetimibe;AUC8, AUCt, Cmax, Tmax and T1/2 of Ezetimibe-glucuronide | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-Heon Cho
Inha University Hospital
Outcome results
None listed