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

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

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
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01527669     History of Changes
Other Study ID Numbers: 201110011MB
First Posted: February 7, 2012    Key Record Dates
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
Red yeast rice
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors