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

Tracking Information

• First Submitted Date: January 12, 2012
• First Posted Date: February 7, 2012
• Last Update Posted Date: July 11, 2012
• Study Start Date: February 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: February 2, 2012)

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

The incidence rate of adverse event

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Subjects

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2012): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01527669
• Other Study ID Numbers: 201110011MB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: National Taiwan University Hospital
• Study Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan

Investigators

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

• PRS Account: National Taiwan University Hospital
• Verification Date: February 2012