Healthy VolunteerPhase 4NCT01269762
Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules
A Phase 4 study testing LipoCol Forte in people with Healthy Volunteer, 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 Volunteer
- What is being tested?
- LipoCol Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Apr 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 in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:
- Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting blood glucose, < 110 milligrams per deciliter (mg/dL).
- Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
- Able to sign informed consent prior to study.
Who cannot join
- Use of any prescription medication within 14 days prior to dosing.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- Participation in any clinical investigation within 3 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.
- Significant illness within 2 weeks prior to dosing.
- Presence of cardiovascular diseases.
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- Presence of gastrointestinal diseases.
- Presence of asthma or lung diseases.
- Presence of liver disease or liver injury.
- Presence of impaired renal function.
- Presence of neurological diseases.
- Presence of psychiatrical diseases.
- Subject is known for Human Immunodeficiency Virus (HIV) infected.
- A known hypersensitivity to lovastatin or its analogs.
- History of drug or alcohol abuse within 12 months prior to dosing.
- 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.
However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still unknown.
The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.
Read the detailed description
This study will divide into two groups, single and multiple doses groups. In single dose group, the subjects will receive one, two and four red yeast rice capsules under fed state in period one to three, respectively. In multiple doses group, the subjects will receive red yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days washout period before crossover of treatments.
In single dose treatment, 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 dosing.
In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the 9th dosing.
- Conditions
- Healthy Volunteer
- Being tested
- LipoCol Forte
- Keywords
- Red yeast rice, Lovastatin, Drug-drug interaction, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoCol ForteDrug
Single dose of one, two and four 600 mg red yeast rice capsules (LipoCol Forte) Multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days
| Study group | Role | What they receive |
|---|---|---|
| LipoCol Forte | Experimental | Subject will receive single dose of one, two and four 600 milligram (mg) red yeast rice capsules (LipoCol Forte)and multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days. Receives: Drug: LipoCol Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerate dosage
The maxium tolerate dosage
Measured: 5 weeks
Secondary outcomes (2)
Evaluation of the pharmacokinetic parameters of LipoCol Forte in healthy subjects
Evaluation of pharmacokinetic parameters of LipoCol Forte in healthy subjects after single and multiple doses
Measured: 5 weeks
The incidence rate of adverse event
The incidence rate of adverse event
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- Yang Jyh-Chin, M.D. Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269762
- Sponsor's protocol ID
- 201001003M
- Status last verified
- Jun 2011
- First submitted
- 21 Dec 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules
- ClinicalTrials.gov ID
- NCT01269762
- Acronym / sponsor ID
- 201001003M
- Conditions
- Healthy Volunteer
- Keywords
- Red yeast rice, Lovastatin, Drug-drug interaction, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jan 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.
However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still unknown.
The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.
Detailed description
This study will divide into two groups, single and multiple doses groups. In single dose group, the subjects will receive one, two and four red yeast rice capsules under fed state in period one to three, respectively. In multiple doses group, the subjects will receive red yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days washout period before crossover of treatments.
In single dose treatment, 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 dosing.
In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the 9th dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LipoCol Forte | Experimental | Drug: LipoCol ForteSubject will receive single dose of one, two and four 600 milligram (mg) red yeast rice capsules (LipoCol Forte)and multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must be at the age of 20-40 years old and in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:
- Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting blood glucose, < 110 milligrams per deciliter (mg/dL).
- Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
- Able to sign informed consent prior to study.
Key exclusion criteria (17 listed)
- Use of any prescription medication within 14 days prior to dosing.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- Participation in any clinical investigation within 3 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.
- Significant illness within 2 weeks prior to dosing.
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 |
|---|---|---|
| LipoCol ForteSingle dose of one, two and four 600 mg red yeast rice capsules (LipoCol Forte) Multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days | Drug | LipoCol Forte |
Primary outcome
The maximum tolerate dosage
Time frame: 5 weeks
The maxium tolerate dosage
2 secondary outcomes
Evaluation of the pharmacokinetic parameters of LipoCol Forte in healthy subjects
Time frame: 5 weeks
The incidence rate of adverse event
Time frame: 5 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 5 Jan 2012.
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Screening Protocol
Pain
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.
Yang Jyh-Chin, 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 LipoCol Forte in people with Healthy Volunteer, 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 5 inclusion and 17 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 5 Jan 2012. 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?
The maximum tolerate dosage (time frame: 5 weeks). 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 5 Jan 2012.