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

Study Overview
=================
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.

Official Title
-----------------
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: LipoCol Forte capsules
* Drug: Lovastatin Tablet


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LipoCol Forte capsules<br>The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. | Drug: LipoCol Forte capsules<br>* The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.<br>|
| Experimental: Lovastatin Tablet<br>The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. | Drug: Lovastatin Tablet<br>* The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects | 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. | 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of adverse event | The incidence rate of adverse event | 1 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Red yeast rice, lovastatin, Pharmacokinetics