The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects - Full Text View

Purpose

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	Intervention	Phase
Healthy Subjects	Drug: LipoCol Forte capsules Drug: Lovastatin Tablet	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.

Resource links provided by NLM:

Drug Information available for: Lovastatin Candida albicans

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects [ Time Frame: 1 weeks ] [ Designated as safety issue: No ]
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:

The incidence rate of adverse event [ Time Frame: 1 weeks ] [ Designated as safety issue: Yes ]
The incidence rate of adverse event


Enrollment:	12
Study Start Date:	February 2012
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


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

Criteria

Inclusion Criteria:

Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
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:

Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
Participation in any clinical investigation within 2 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.
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).
Creatine kinase (CK) value greater than 1.5-fold normal value.
A known hypersensitivity to statins or their analogs.
Permanent confinement to an institution.
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: NCT01527669

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

No publications provided by National Taiwan University Hospital

Additional 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 History of Changes
Other Study ID Numbers:	201110011MB
Study First Received:	January 12, 2012
Last Updated:	July 9, 2012
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:


Red yeast rice lovastatin Pharmacokinetics

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015