Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01269762
First received: December 21, 2010
Last updated: January 2, 2012
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: LipoCol Forte
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The maximum tolerate dosage [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    The maxium tolerate dosage


Secondary Outcome Measures:
  • Evaluation of the pharmacokinetic parameters of LipoCol Forte in healthy subjects [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Evaluation of pharmacokinetic parameters of LipoCol Forte in healthy subjects after single and multiple doses

  • The incidence rate of adverse event [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    The incidence rate of adverse event


Enrollment: 14
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LipoCol Forte
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.
Drug: LipoCol Forte
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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).

  3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
  4. Able to sign informed consent prior to study.

Exclusion Criteria:

  1. Use of any prescription medication within 14 days prior to dosing.
  2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
  3. Participation in any clinical investigation within 3 months prior to dosing or longer as required by local regulation.
  4. Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
  5. Significant illness within 2 weeks prior to dosing.
  6. Presence of cardiovascular diseases.
  7. Presence of gastrointestinal diseases.
  8. Presence of asthma or lung diseases.
  9. Presence of liver disease or liver injury.
  10. Presence of impaired renal function.
  11. Presence of neurological diseases.
  12. Presence of psychiatrical diseases.
  13. Subject is known for Human Immunodeficiency Virus (HIV) infected.
  14. A known hypersensitivity to lovastatin or its analogs.
  15. History of drug or alcohol abuse within 12 months prior to dosing.
  16. Permanent confinement to an institution.
  17. Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269762

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Yang Jyh-Chin, M.D. Ph.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01269762     History of Changes
Other Study ID Numbers: 201001003M
Study First Received: December 21, 2010
Last Updated: January 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Red yeast rice
Lovastatin
Drug-drug interaction
Pharmacokinetics

Additional relevant MeSH terms:
Red yeast rice
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014