The Interaction of Herbs and Statins

NCT05072405 | Completed Phase 4

• 1 other identifier: herbals
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Interaction

Keywords

Statins

Outcome Measures

Primary Outcomes (4)

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

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

  14 weeks

• The interactions of green tea extract and soy isoflavones on the area under plasma concentration-time curve of simvastatin

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

  14 weeks

• The interactions of green tea extract and soy isoflavones on the maximum plasma concentration of rosuvastatin

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

  14 weeks

• The interactions of green tea extract and soy isoflavones on the area under plasma concentration-time curve of rosuvastatin

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

  14 weeks

Secondary Outcomes (4)

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

  14 weeks

• The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of simvastatin and the interaction with herbs.

  14 weeks

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

  14 weeks

• The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of rosuvastatin and the interaction with herbs.

  14 weeks

Study Arms (2)

simvastatin 20 mg (Zocor®, MSD)

OTHER

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)

rosuvastatin 10 mg (Crestor®, Astra Zeneca)

OTHER

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)

Interventions

Simvastatin 20 mg (Zocor®, MSD) DRUG

Simvastatin 20 mg given once alone, once with green tea extract and once with soy isoflavones extract.

Also known as: Green tea extract, Soy isoflavones extract

simvastatin 20 mg (Zocor®, MSD)

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.

Also known as: Green tea extract, Soy isoflavones extract

rosuvastatin 10 mg (Crestor®, Astra Zeneca)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Female
• Patients with any disease
• Volunteers who cannot follow the instructions
• Volunteers who don't sign the informed consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Simvastatin; Tea; Soybean Proteins; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Soy Foods; Vegetable Products; Vegetables; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• BRIAN TOMLINSON, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones), once with rosuvastatin and once with simvastatin.

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: October 8, 2021
• Study Start: January 11, 2013
• Primary Completion: December 30, 2013
• Study Completion: August 28, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

HK (1)