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CUHK_CCT00353
2013-01-19
Prospective
Nil
Health and Health Services Research Fund (Food and Health Bureau, HKSAR)
CUHK
N/A
Benny Fok
Flat B, 6/F, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
(852) 2632-3377
bfok@cuhk.edu.hk
The Chinese University of Hong Kong
Brian Tomlinson
Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
(852) 2632-3139
btomlinson@cuhk.edu.hk
The Chinese University of Hong Kong
Interactions of herbs with statin drugs and potential mediation by drug transporters
Interactions of herbs with statin drugs and potential mediation by drug transporters
草本植物與他汀類藥物的相互作用以及藥物運輸蛋白在其中的潛在介導作用
Statin-herb interactions
Hong Kong
Yes
2011-01-05
Healthy Volunteers
Drug
Simvastatin 20mg/ Rosuvastatin 10mg/
Green Tea Extract 400mg/ Soy Isoflavone 60mg
Simvastatin (3 days) / Rosuvastatin (3 days) /
Green Tea Extract (15 days)/ Soy Isoflavone (15 day
Nil
No significant abnormalities in general physical examination; ECG recording within normal limits; Biochemical and haematological parameters within normal or upon Investigator decision; Genotypes of SLCO1B1 388A>G, 521T>C and ABCG2 421C>A are available
History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study; Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test or upon Investigator decision; Tobacco use in any forms; Regular consumer of alcohol; Blood donation within 4 weeks prior to the start of the study; Treatment of statins within 4 weeks before the study; Volunteer in any clinical drug study within 2 months prior to this study; Consumption of tea, grapefruit juice, caffeine, xanthine-containing foods or beverages, soybean product, any dietary supplements or herbal products 2 weeks before screening; History of allergy or hypertensitivity to statins, tea, or soybean product.
18
55
Male
Interventional
Non-randomized
Active
Open label
Single group
2013-03-02
36
Not Yet Recruiting
Differences in statin pharmacokinetic parameters with and without herb consumptions
Difference in pharmacokinetic parameters and interactions among genotype groups
2014-02-20
ChiCTR-ONC-13003007
2013-01-19
Yes
n/a
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