The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT01527669
• Recruitment Status: Completed
• First Posted: February 7, 2012
• Last Update Posted: July 11, 2012
• Sponsor: National Taiwan University Hospital
• Collaborator: National Science Council, Taiwan
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

Brief Summary:

The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet after single oral administration in healthy subjects.

Condition or disease	Intervention/treatment	Phase
Healthy Subjects	Drug: LipoCol Forte capsules; Drug: Lovastatin Tablet	Phase 4

Detailed Description:

This study is two-ways crossover design. The subjects will receive a dose of four 600 mg LipoCol Forte Capsules or 20 mg Mevacor Tablet in fasted state in the morning. There is a minimum of a 6-days washout period before crossover of treatments.

Each subject will be admitted before administration of the investigational product in each period. Study responsible personnel will give the subjects a single tablet or four capsules in fasted state in the morning. The blood samples will be drawn prior to the dosing, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.

Observations will be conducted up to 12 hours after the dosing. If no particular health abnormalities are observed in each period, the subjects will be discharged on 12 hours after the dosing.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
• Study Start Date: February 2012
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: LipoCol Forte capsules; The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.	Drug: LipoCol Forte capsules; The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
Experimental: Lovastatin Tablet; The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.	Drug: Lovastatin Tablet; The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Outcome Measures

Primary Outcome Measures :

1. Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects [ Time Frame: 1 weeks ]
   Plasma concentrations of lovastatin and lovastatin acid were detected at following time: (Pre-dose (T0), and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol Forte)or lovastatin. All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods.

Secondary Outcome Measures :

1. The incidence rate of adverse event [ Time Frame: 1 weeks ]
   The incidence rate of adverse event

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
2. Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
3. No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.

Exclusion Criteria:

1. Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
2. Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
3. Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
4. Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
5. Creatine kinase (CK) value greater than 1.5-fold normal value.
6. A known hypersensitivity to statins or their analogs.
7. Permanent confinement to an institution.
8. Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.

Contacts and Locations

Locations

Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

National Science Council, Taiwan

Investigators

• Principal Investigator: Jyh-Chin Yang, M.D. Ph.D; National Taiwan University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen CH, Yang JC, Uang YS, Lin CJ. Improved dissolution rate and oral bioavailability of lovastatin in red yeast rice products. Int J Pharm. 2013 Feb 28;444(1-2):18-24. doi: 10.1016/j.ijpharm.2013.01.028. Epub 2013 Jan 23.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01527669
• Other Study ID Numbers: 201110011MB
• First Posted: February 7, 2012
• Last Update Posted: July 11, 2012
• Last Verified: February 2012

Keywords provided by National Taiwan University Hospital:

Red yeast rice; lovastatin; Pharmacokinetics

Additional relevant MeSH terms:

Lovastatin; L 647318; Dihydromevinolin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors