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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01527669
First received: January 12, 2012
Last updated: July 9, 2012
Last verified: February 2012
History of Changes

January 12, 2012
July 9, 2012
February 2012
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01527669 on ClinicalTrials.gov Archive Site
The incidence rate of adverse event [ Time Frame: 1 weeks ] [ Designated as safety issue: Yes ]
The incidence rate of adverse event
Same as current
Not Provided
Not Provided
 
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
  • Drug: LipoCol Forte capsules
    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.
  • Experimental: LipoCol Forte capsules
    The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
    Intervention: Drug: LipoCol Forte capsules
  • Experimental: Lovastatin Tablet
    The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
    Intervention: Drug: Lovastatin Tablet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01527669
201110011MB
No
Not Provided
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: Jyh-Chin Yang, M.D. Ph.D National Taiwan University Hospital
National Taiwan University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP