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

NCT01346670 | Completed Phase 4

• 1 other identifier: F950802
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Red yeast rice; Lovastatin; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Evaluation of the relative bioavailability by plasma concentration of LipoCol and lovastatin

  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.

  1 week

Secondary Outcomes (1)

• The incidence rate of adverse event

  1 week

Study Arms (1)

LipoCol and Mevacor

EXPERIMENTAL

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

Drug: LipoCol and Mevacor

Interventions

LipoCol and Mevacor DRUG

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.

LipoCol and Mevacor

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).
• Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
• Able to sign informed consent prior to study.
• Able to communicate well with the investigator and comply with the requirements of the study.

You may not qualify if:

• Use of any prescription medication within 14 days prior to dosing.
• Use of over-the-counter medications or vitamins within 14 days prior to dosing.
• Significant illness within 2 weeks prior to dosing.
• Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
• Donate or loss more than 500 milliliter (mL) of blood within 3 months prior to dosing.
• Presence of cardiovascular disease.
• Presence of gastrointestinal disease.
• Presence of asthma or lung disease.
• Presence of liver disease or liver injury as indicated by an abnormal liver function profile.
• Presence of impaired renal function.
• Presence of neurological disease.
• Presence of psychiatrical disease.
• A known hypersensitivity to lovastatin and Chinese Red Yeast Rice or their analogs.
• History of drug or alcohol abuse within 12 months prior to dosing.
• Permanent confinement to an institution.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chen CH, Yang JC, Uang YS, Lin CJ. Improved dissolution rate and oral bioavailability of lovastatin in red yeast rice products. Int J Pharm. 2013 Feb 28;444(1-2):18-24. doi: 10.1016/j.ijpharm.2013.01.028. Epub 2013 Jan 23.

  PMID: 23352857 DERIVED

MeSH Terms

Interventions

Lovastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Liu Hsin-Gjin Eugene, M.D. Ph.D.

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 3, 2011
• Study Start: October 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

TW (1)