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

NCT ID: NCT01527669

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-02-29

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.

Conditions

Healthy Subjects

Keywords

Red yeast rice; lovastatin; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LipoCol Forte capsules

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Group Type: EXPERIMENTAL

LipoCol Forte capsules

Intervention Type: DRUG

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Lovastatin Tablet

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Group Type: EXPERIMENTAL

Lovastatin Tablet

Intervention Type: DRUG

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Interventions

LipoCol Forte capsules

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Intervention Type: DRUG

Lovastatin Tablet

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyh-Chin Yang, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 23352857 (View on PubMed)

Other Identifiers

201110011MB

Identifier Type: -

Identifier Source: org_study_id