None listed
Conditions
Interventions
Drug : 1. rosuvastatin 20 mg single oral administration
2. rosuvastatin 20 mg + EGCG 300 mg single oral administration
3. rosuvastatin 20 mg+ EGCG 300 mg single oral administration after oral admin
Sponsors
Konkuk University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult aged 20-55 2) Subject who can restrict diet including green tea or fruit juice 3) Subject who gave an written informed consent by listening to the purpose of study, content of study and investigational drug
Exclusion criteria
Exclusion criteria: 1) Subject who has or had a clinically significant abnormality in liver, kidney, respiratory, muscle&skeletal, psychiatric, hemato-oncology or cardiovastular systems 2) Subject who has a history of significant allergic reaction to rosuvastatin or drug of same class to rosuvastatin, to catechin or to other drugs(aspirin, antibiotics, etc. 3) Subject who received other investigational drug within 60 days from screening 4) Subject who donated whole blood within 60 days from screening or blood component within 30 days from screening 5) Subject who received drugs or food which induce or inhibit organic anion-transporting polypeptide (OATP) or breast cancer resistance protein (BCRP)-gemfibrozil, cyclosporin, lopinavir/ritonavir etc.- within 2 weeks from screening 6) Subject who drinks alcohol >140 g/week 7) Subject who smokes >20 cigarettes/day 8) Subject whose serology test(HBV, HCV or HIV) is positive 9) Subject whose AST, ALT or total bilirubin is > 1.5 folds of upper normal limit 10) Subject whose glomerular filtration rate (GFR) estimated by Modification of Diet in Renal Disease (MDRD) equation is below normal range 11) Subject whose systolic blood pressure is <=90 mmHg or>=160 mmHg or diastolic blood pressure is <=50 mmHg or>=100 mmHg 12) Subject who is judged inadequate by investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve(AUC0-8) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Eun Kim
Konkuk University Medical Center
Outcome results
None listed