Status:
COMPLETED
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-40 years
Phase:
PHASE4
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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01527669
Start Date
February 1 2012
End Date
February 1 2012
Last Update
July 11 2012
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan