Healthy Volunteer
Conditions
Keywords
Red yeast rice, Lovastatin, Bioavailability
Brief summary
The objective of the study is to evaluate the relative bioavailability of lovastatin and its ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor® Tablet after single oral administration in healthy subjects using a 2x2 crossover design.
Detailed description
Healthy subjects were randomly allocated to receive a single dose of either four 600 mg red yeast rice capsules or one 20 mg lovastatin tablet; after 7-day washout period, they received a single dose of the alternative drug. The subjects were fasted at least 10 hour before dosing. The investigational products were administered with 240 mL of water with the subject in an upright position. The blood samples were collected at prior to the drug administration (T0), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after dosing.
Interventions
DRUGLipoCol and Mevacor
To evaluate the relative bioavailability of lovastatin and its ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor® Tablet after single oral administration in healthy subjects using a 2x2 crossover design.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be at the age of 20-40 years old and in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations. 2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting blood glucose, \< 110 milligrams per deciliter (mg/dL). 3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight. 4. Able to sign informed consent prior to study. 5. Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria
1. Use of any prescription medication within 14 days prior to dosing. 2. Use of over-the-counter medications or vitamins within 14 days prior to dosing. 3. Significant illness within 2 weeks prior to dosing. 4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation. 5. Donate or loss more than 500 milliliter (mL) of blood within 3 months prior to dosing. 6. Presence of cardiovascular disease. 7. Presence of gastrointestinal disease. 8. Presence of asthma or lung disease. 9. Presence of liver disease or liver injury as indicated by an abnormal liver function profile. 10. Presence of impaired renal function. 11. Presence of neurological disease. 12. Presence of psychiatrical disease. 13. A known hypersensitivity to lovastatin and Chinese Red Yeast Rice or their analogs. 14. History of drug or alcohol abuse within 12 months prior to dosing. 15. Permanent confinement to an institution. 16. Pregnant or lactating women. 17. Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the relative bioavailability by plasma concentration of LipoCol and lovastatin | 1 week | Plasma concentration of lovastatin and lovastatin acid were detected at following time: (Pre-dose (T0) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after oral administration of red yeast rice capsules (LipoCol) and lovastatin tablet.) All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of adverse event | 1 week | The incidence rate of adverse event |
Countries
Taiwan
Outcome results
None listed