Skip to main content
OpenTrials
Completed

NCT Number: NCT05072405

The Interaction of Herbs and Statins

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Interaction

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simvastatin 20 mg (Zocor®, MSD)

Drug

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

rosuvastatin 10 mg (Crestor®, Astra Zeneca)

Drug

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

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Interactions of Herbs With Statin Drugs and Potential Mediation by Drug Transporters

Important dates

Study start
2013
Primary completion
2013
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.