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The Interaction of Herbs and Statins

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT05072405
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
103.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project includes two separate pharmacokinetic studies with simvastatin and rosuvastatin, respectively. Each study is an open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones) clinical pharmacokinetic study design with a wash-out of at least 4-weeks between phases. The aim is to examine whether green tea extract and soy isoflavones affect the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects and whether these interactions are influenced by polymorphisms in the relevant drug transporters, solute carrier 1B1 (SLCO1B1) and adenosine triphosphate (ATP) binding cassette G2 (ABCG2) and to identify whether polymorphisms in drug transporters influence the pharmacokinetics of simvastatin and rosuvastatin. After informed consent is obtained, subjects are required to abstain from any prescription or non-prescription medications 2 weeks before and throughout the study. Subjects are given a single dose of simvastatin 20 mg (Zocor®, MSD) or rosuvastatin 10 mg (Crestor®, Astra Zeneca) on 3 occasions: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract. The green tea extract and soy isoflavones extract are given at a dose containing epigallocatechin gallate (EGCG) 800 mg once daily or isoflavones 120 mg once daily for 14 days before statin dosing with at least 4-week washout period between phases. Blood samples are taken at intervals from 0 to 24 hours on the statin dosing days. During the study, subjects are reminded frequently of the requirements on diet.

Condition or Disease Intervention/Treatment Phase
  • Drug: Simvastatin 20 mg (Zocor®, MSD)
  • Drug: rosuvastatin 10 mg (Crestor®, Astra Zeneca)
 Phase 4

Detailed Description

Healthy Chinese male subjects aged 18-45 years are recruited from a pool of over 200 healthy volunteers who had been genotyped for the SLCO1B1 388A>G, 521T>C and ABCG2 421C>A polymorphisms. All subjects are required to abstain from any prescription or non-prescription medications 2 weeks before and throughout the study. They are not allowed to take alcohol, tea, grapefruit juice, caffeine, soybean milk or dietary supplements and herbal products 2 weeks before and throughout the entire study period. They are also not allowed to smoke 2 weeks before and throughout the study. Subjects are requested to fast for 10 h before and 4 h after drug administration during the blood sampling sessions. Meals are standardized and consumed at 4 h and 10 h post dosing. Drinking water are not allowed from 1 h pre-dose to 1 h post-dose except that needed for drug dosing at the time of blood sampling sessions. Subjects are given a single dose of simvastatin 20 mg (Zocor®, MSD) or rosuvastatin 10 mg (Crestor®, Astra Zeneca) on 3 occasions: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract. The green tea extract and soy isoflavones extract are given at a dose containing EGCG 800 mg once daily or isoflavones 120 mg once daily for 14 days before statin dosing with at least 4-week washout period between phases.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones), once with rosuvastatin and once with simvastatin.Open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones), once with rosuvastatin and once with simvastatin.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Interactions of Herbs With Statin Drugs and Potential Mediation by Drug Transporters
Actual Study Start Date :
Jan 11, 2013
Actual Primary Completion Date :
Dec 30, 2013
Actual Study Completion Date :
Aug 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: simvastatin 20 mg (Zocor®, MSD)

simvastatin 20 mg are given on 3 occasions: 1. without herbs; 2. with green tea extract containing EGCG 800 mg once daily for 14 days before statin dosing; 3. with soy isoflavones extract containing isoflavones 120 mg once daily for 14 days before statin dosing, with at least 4-week washout period between phases.

Drug: Simvastatin 20 mg (Zocor®, MSD)
Simvastatin 20 mg given once alone, once with green tea extract and once with soy isoflavones extract.
Other Names:
  • Green tea extract
  • Soy isoflavones extract

    		•
    Other: rosuvastatin 10 mg (Crestor®, Astra Zeneca)

    rosuvastatin 10 mg are given on 3 occasions: 1. without herbs; 2. with green tea extract containing EGCG 800 mg once daily for 14 days before statin dosing; 3. with soy isoflavones extract containing isoflavones 120 mg once daily for 14 days before statin dosing, with at least 4-week washout period between phases

    Drug: rosuvastatin 10 mg (Crestor®, Astra Zeneca)
    rosuvastatin 10 mg are given once alone, once with green tea extract and once with soy isoflavones extract.
    Other Names:
  • Green tea extract
  • Soy isoflavones extract

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The interactions of green tea extract and soy isoflavones on the maximum plasma concentration of simvastatin [14 weeks]

      Maximum plasma concentration for simvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract.

    2. The interactions of green tea extract and soy isoflavones on the area under plasma concentration-time curve of simvastatin [14 weeks]

      Area under plasma concentration-time curve for simvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract.

    3. The interactions of green tea extract and soy isoflavones on the maximum plasma concentration of rosuvastatin [14 weeks]

      Maximum plasma concentration for rosuvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract.

    4. The interactions of green tea extract and soy isoflavones on the area under plasma concentration-time curve of rosuvastatin [14 weeks]

      Area under plasma concentration-time curve for rosuvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract.

    Secondary Outcome Measures

    1. The influence of polymorphisms in drug transporters on the maximum plasma concentration of simvastatin and the interaction with herbs. [14 weeks]

      Maximum plasma concentration for simvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract with subjects divided according to genotypes of drug transporters.

    2. The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of simvastatin and the interaction with herbs. [14 weeks]

      Area under plasma concentration-time curve for simvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract with subjects divided according to genotypes of drug transporters.

    3. The influence of polymorphisms in drug transporters on the maximum plasma concentration of rosuvastatin and the interaction with herbs. [14 weeks]

      Maximum plasma concentration for rosuvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract with subjects divided according to genotypes of drug transporters.

    4. The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of rosuvastatin and the interaction with herbs. [14 weeks]

      Area under plasma concentration-time curve for rosuvastatin comparing: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract with subjects divided according to genotypes of drug transporters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy Chinese male subjects aged 18 - 45 years

    • healthy volunteers who had been genotyped for the SLCO1B1 388A>G, 521T>C and ABCG2 421C>A polymorphisms.

    Exclusion Criteria:

    • Female

    • Patients with any disease

    • Volunteers who cannot follow the instructions

    • Volunteers who don't sign the informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese University of Hong Kong Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: BRIAN TOMLINSON, MD, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Tomlinson, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05072405
    Other Study ID Numbers:
    • herbals
    First Posted:
    Oct 8, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Brian Tomlinson, Professor, Chinese University of Hong Kong
    Statins
    Additional relevant MeSH terms:
    Rosuvastatin Calcium
    Simvastatin

    Study Results

    No Results Posted as of Oct 8, 2021