Pharmacokinetics study to evaluate the effect of green tea on rosuvastati

Not Applicable

Active, not recruiting

• Conditions: Not Applicable

• Registration Number: KCT0002186
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 13

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

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve(AUC0-8)