Lovastatin and Its ß-hydroxy Acid From Four 600 mg LipoCol Forte® Capsules Compared to That of One 20 mg Mevacor® Tablet in Healthy Subjects

Phase 4

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: LipoCol and Mevacor

• Registration Number: NCT01346670
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2011-04-27
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-01
• Last Update Submitted: 2011-05-01
• Study First Posted: 2011-05-03
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LipoCol and Mevacor	LipoCol 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The incidence rate of adverse event	1 week	The incidence rate of adverse event

Trial Locations

Locations (1)

Taipei Medical University - WanFang Hospital; 🇨🇳 Taipei, Taiwan