Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00353

2 Trial Registration Date

2013-01-19

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Health and Health Services Research Fund (Food and Health Bureau, HKSAR)

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Benny Fok

ii Address

Flat B, 6/F, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

iii Phone

(852) 2632-3377

iv Email

bfok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Brian Tomlinson

ii Address

Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

iii Phone

(852) 2632-3139

iv Email

btomlinson@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Interactions of herbs with statin drugs and potential mediation by drug transporters

10 Public Title

Interactions of herbs with statin drugs and potential mediation by drug transporters

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Statin-herb interactions

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-01-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Healthy Volunteers

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Simvastatin 20mg/ Rosuvastatin 10mg/
Green Tea Extract 400mg/ Soy Isoflavone 60mg

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Simvastatin (3 days) / Rosuvastatin (3 days) /
Green Tea Extract (15 days)/ Soy Isoflavone (15 day

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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.

iii Age Minimum

18

iv Age Maximum

55

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-03-02

21 Target Sample Size

36

22 Recruitment Status

Unknown

23 Primary Outcome

Differences in statin pharmacokinetic parameters with and without herb consumptions

24 Secondary Outcome

Difference in pharmacokinetic parameters and interactions among genotype groups

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-02-20

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-13003007

28 Date of Registration in Primary Registry

2013-01-19

Back History

Trial Detail