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Trial History Detail on 2013-04-26

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

No

2014-02-20

ChiCTR-ONC-13003007

2013-01-19


Yes

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