Healthy Subjects Clinical Trial
Official title:
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
Verified date | February 2012 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | The incidence rate of adverse event | The incidence rate of adverse event | 1 weeks | Yes |
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