Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 231 for:    yeast

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01527669
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : July 11, 2012
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE January 12, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date July 11, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01527669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
The incidence rate of adverse event [ Time Frame: 1 weeks ]
The incidence rate of adverse event
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
Official Title  ICMJE The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01527669
Other Study ID Numbers  ICMJE 201110011MB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Jyh-Chin Yang, M.D. Ph.D National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date February 2012

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