Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules

NCT01269762 | Completed Phase 4

• 1 other identifier: 201001003M
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Red yeast rice; Lovastatin; Drug-drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The maximum tolerate dosage

  The maxium tolerate dosage

  5 weeks

Secondary Outcomes (2)

• Evaluation of the pharmacokinetic parameters of LipoCol Forte in healthy subjects

  5 weeks

• The incidence rate of adverse event

  5 weeks

Study Arms (1)

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.

Drug: LipoCol Forte

Interventions

LipoCol Forte DRUG

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

LipoCol Forte

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

• Yang Jyh-Chin, M.D. Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: January 4, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2011-06

Locations

TW (1)