Drug InteractionPhase 4NCT05072405
The Interaction of Herbs and Statins
A Phase 4 study testing Simvastatin 20 mg (Zocor®, MSD) and rosuvastatin 10 mg (Crestor®, Astra Zeneca) in people with Drug Interaction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Simvastatin 20 mg (Zocor®, MSD) and rosuvastatin 10 mg (Crestor®, Astra Zeneca)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jan 2013to 28 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Female
- Patients with any disease
- Volunteers who cannot follow the instructions
- Volunteers who don't sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interactions of Herbs With Statin Drugs and Potential Mediation by Drug Transporters
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.
Read the 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.
- Conditions
- Drug Interaction
- Being tested
- Simvastatin 20 mg (Zocor®, MSD), rosuvastatin 10 mg (Crestor®, Astra Zeneca)
- Keywords
- Statins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 20 mg (Zocor®, MSD)Drug
Also called Green tea extract, Soy isoflavones extract
Simvastatin 20 mg given once alone, once with green tea extract and once with soy isoflavones extract.
rosuvastatin 10 mg (Crestor®, Astra Zeneca)Drug
Also called Green tea extract, Soy isoflavones extract
rosuvastatin 10 mg are given once alone, once with green tea extract and once with soy isoflavones extract.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: rosuvastatin 10 mg (Crestor®, Astra Zeneca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 weeks
Secondary outcomes (4)
The influence of polymorphisms in drug transporters on the maximum plasma concentration of simvastatin and the interaction with herbs.
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.
Measured: 14 weeks
The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of simvastatin and the interaction with herbs.
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.
Measured: 14 weeks
The influence of polymorphisms in drug transporters on the maximum plasma concentration of rosuvastatin and the interaction with herbs.
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.
Measured: 14 weeks
The influence of polymorphisms in drug transporters on the area under plasma concentration-time curve of rosuvastatin and the interaction with herbs.
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start11 Jan 2013
- Primary completion30 Dec 2013
- Study completion28 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Tomlinson, Chinese University of Hong Kong
- Investigators
- BRIAN TOMLINSON, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072405
- Sponsor's protocol ID
- herbals
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions of Herbs With Statin Drugs and Potential Mediation by Drug Transporters
- ClinicalTrials.gov ID
- NCT05072405
- Acronym / sponsor ID
- herbals
- Conditions
- Drug Interaction
- Keywords
- Statins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Jan 2013 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 28 Aug 2021 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, single-dose, randomized, three-phase (no herbs, with green tea, with soy isoflavones), once with rosuvastatin and once with simvastatin.
| Arm | Type | Receives |
|---|---|---|
| simvastatin 20 mg (Zocor®, MSD) | Other | Drug: 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. |
| rosuvastatin 10 mg (Crestor®, Astra Zeneca) | Other | Drug: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Female
- Patients with any disease
- Volunteers who cannot follow the instructions
- Volunteers who don't sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 20 mg (Zocor®, MSD)Also: Green tea extract, Soy isoflavones extractSimvastatin 20 mg given once alone, once with green tea extract and once with soy isoflavones extract. | Drug | simvastatin 20 mg (Zocor®, MSD) |
| rosuvastatin 10 mg (Crestor®, Astra Zeneca)Also: Green tea extract, Soy isoflavones extractrosuvastatin 10 mg are given once alone, once with green tea extract and once with soy isoflavones extract. | Drug | rosuvastatin 10 mg (Crestor®, Astra Zeneca) |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
The influence of polymorphisms in drug transporters on the maximum plasma concentration of simvastatin and the interaction with herbs.
Time frame: 14 weeks
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
The influence of polymorphisms in drug transporters on the maximum plasma concentration of rosuvastatin and the interaction with herbs.
Time frame: 14 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BRIAN TOMLINSON, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 20 mg (Zocor®, MSD) and rosuvastatin 10 mg (Crestor®, Astra Zeneca) in people with Drug Interaction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The interactions of green tea extract and soy isoflavones on the maximum plasma concentration of simvastatin (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.