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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: National Science Council, Taiwan
• Treatments: Dihydromevinolin; L 647318; Lovastatin; Red yeast rice

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.