Healthy SubjectsPhase 4NCT01385020
Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects
A Phase 4 study testing Gemfibrozil & red yeast rice (LipoCol) in people with Healthy Subjects, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a significant cholesterol lowering effect which might be caused by addictive and/or synergistic effects of lovastatin (monacolin K) with other monacolins and substances in capsules. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Gemfibrozil & red yeast rice (LipoCol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jul 2011
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
- Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
- No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
Who cannot join
- Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
- Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
- Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
- Creatine kinase (CK) value greater than 1.5-fold normal value.
- A known hypersensitivity to statins and fibrates or their analogs.
- Permanent confinement to an institution.
- Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a significant cholesterol lowering effect which might be caused by addictive and/or synergistic effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule twice/day.
Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although the combination of a fibrate and a statin is highly effective,concerns about an increased incidence of myopathy and even rhabdomyolysis have limited the widespread use of such combinations. Such combination therapies are prone to drug-drug interactions, which can lead to altered pharmacokinetic profiles of either drug, an effect observed for many statins in combination with fibrates. However, the drug-drug interactions have not been reported between red yeast rice capsule and gemfibrozil.
The objective of the study is to evaluate the effect of gemfibrozil on the plasma concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice capsule in healthy volunteers. In addition, the investigators also measure the plasma concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.
Read the detailed description
A randomized,crossover study design with 2 periods was used. The washout time between the periods was 4 days. In first period, 600 mg red yeast rice capsule (LipoCol) was administered orally with 240 mL water at 8 AM. In second period, subjects took 600 mg gemfibrozil (two Lopid 300-mg capsule) at 7 AM and 7 PM for 2 days. On day 3, subjects took 600 mg gemfibrozil at 7 AM then 600 mg red yeast rice capsule was administered orally with 240 mL water at 8 AM. The volunteers had fasted overnight, a breakfast and dinner was severed 0.5 hour after the administration of gemfibrozil. In addition, a high fat breakfast was served 0.5 hour before and standard meal was served 4 and 10 hours after the administration of red yeast rice (LipoCol).
The blood samples will be drawn prior to the dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the administration of red yeast rice(LipoCol)for detecting the plasma concentration of lovastatin and lovastatin acid. In addition, the blood samples will be drawn prior to the dosing, and 1, 2, 4, 6 and 12 hours after the administration of red yeast rice (LipoCol) for detecting the plasma concentration of creatine kinase (CK) and co-enzyme Q10.
- Conditions
- Healthy Subjects
- Being tested
- Gemfibrozil & red yeast rice (LipoCol)
- Keywords
- Red yeast rice, Gemfibrozil, Drug-drug interaction, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemfibrozil & red yeast rice (LipoCol)Drug
The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Gemfibrozil & red yeast rice (LipoCol) | Experimental | The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects Receives: Drug: Gemfibrozil & red yeast rice (LipoCol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects
Plasma concentrations of lovastatin and lovastatin acid were detected at following time: (Pre-dose (T0), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol) with or without gemfibrozil All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods.
Measured: 1 week
Secondary outcomes (1)
Evaluation of the plasma concentration of creatine kinase (CK) and co-enzyme Q10 in healthy subjects
Plasma concentrations of creatine kinase (CK) and co-enzyme Q10 were detected at following time: (Pre-dose (T0), and 1, 2, 4, 6, and 12 hours after oral administration red yeast rice capsule (LipoCol) with or without gemfibrozil)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jyh-Chin Yang, M.D. Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385020
- Sponsor's protocol ID
- 201105057MC
- Status last verified
- Aug 2011
- First submitted
- 28 Jun 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01385020
- Acronym / sponsor ID
- 201105057MC
- Conditions
- Healthy Subjects
- Keywords
- Red yeast rice, Gemfibrozil, Drug-drug interaction, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jun 2011 (estimated)
- 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.
Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a significant cholesterol lowering effect which might be caused by addictive and/or synergistic effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule twice/day.
Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although the combination of a fibrate and a statin is highly effective,concerns about an increased incidence of myopathy and even rhabdomyolysis have limited the widespread use of such combinations. Such combination therapies are prone to drug-drug interactions, which can lead to altered pharmacokinetic profiles of either drug, an effect observed for many statins in combination with fibrates. However, the drug-drug interactions have not been reported between red yeast rice capsule and gemfibrozil.
The objective of the study is to evaluate the effect of gemfibrozil on the plasma concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice capsule in healthy volunteers. In addition, the investigators also measure the plasma concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.
Detailed description
A randomized,crossover study design with 2 periods was used. The washout time between the periods was 4 days. In first period, 600 mg red yeast rice capsule (LipoCol) was administered orally with 240 mL water at 8 AM. In second period, subjects took 600 mg gemfibrozil (two Lopid 300-mg capsule) at 7 AM and 7 PM for 2 days. On day 3, subjects took 600 mg gemfibrozil at 7 AM then 600 mg red yeast rice capsule was administered orally with 240 mL water at 8 AM. The volunteers had fasted overnight, a breakfast and dinner was severed 0.5 hour after the administration of gemfibrozil. In addition, a high fat breakfast was served 0.5 hour before and standard meal was served 4 and 10 hours after the administration of red yeast rice (LipoCol).
The blood samples will be drawn prior to the dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the administration of red yeast rice(LipoCol)for detecting the plasma concentration of lovastatin and lovastatin acid. In addition, the blood samples will be drawn prior to the dosing, and 1, 2, 4, 6 and 12 hours after the administration of red yeast rice (LipoCol) for detecting the plasma concentration of creatine kinase (CK) and co-enzyme Q10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemfibrozil & red yeast rice (LipoCol) | Experimental | Drug: Gemfibrozil & red yeast rice (LipoCol)The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
- Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
- No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
Key exclusion criteria (8 listed)
- Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
- Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
- Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
- Creatine kinase (CK) value greater than 1.5-fold normal value.
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 |
|---|---|---|
| Gemfibrozil & red yeast rice (LipoCol)The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects. | Drug | Gemfibrozil & red yeast rice (LipoCol) |
Primary outcome
Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects
Time frame: 1 week
Plasma concentrations of lovastatin and lovastatin acid were detected at following time: (Pre-dose (T0), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol) with or without gemfibrozil All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods.
1 secondary outcome
Evaluation of the plasma concentration of creatine kinase (CK) and co-enzyme Q10 in healthy subjects
Time frame: 1 week
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 17 Oct 2011.
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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.
Jyh-Chin Yang, M.D. Ph.D. principal investigator
National Taiwan University Hospital
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 Gemfibrozil & red yeast rice (LipoCol) in people with Healthy Subjects, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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 17 Oct 2011. 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 Taiwan. 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?
Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects (time frame: 1 week). 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 17 Oct 2011.