Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

Healthy Volunteer Clinical Trial

Official title:

Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269762
• Other study ID #: 201001003M
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2010
• Last updated: January 2, 2012
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerate dosage	The maxium tolerate dosage	5 weeks	No
Secondary	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	No
Secondary	The incidence rate of adverse event	The incidence rate of adverse event	5 weeks	Yes