Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: LipoCol Forte

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum tolerate dosage	The maxium tolerate dosage	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks
The incidence rate of adverse event	The incidence rate of adverse event	5 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Yang Jyh-Chin, M.D. Ph.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: January 2, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 2, 2012
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Red yeast rice; Drug-drug interaction; Lovastatin
• Other Study ID Numbers: 201001003M