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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

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01346670
First received: April 27, 2011
Last updated: May 1, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: LipoCol and Mevacor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-randomized, Balanced, Crossover Relative Bioavailability Study of 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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Evaluation of the relative bioavailability by plasma concentration of LipoCol and lovastatin [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • The incidence rate of adverse event [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    The incidence rate of adverse event


Enrollment: 14
Study Start Date: October 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346670

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Liu Hsin-Gjin Eugene, M.D. Ph.D. Taipei Medical University WanFang Hospital
  More Information

No publications provided by Taipei Medical University WanFang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hsingjin Eugene Liu, MD PhD, Department of Hematology-oncology, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01346670     History of Changes
Other Study ID Numbers: F950802
Study First Received: April 27, 2011
Last Updated: May 1, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Red yeast rice
Lovastatin
Bioavailability

Additional relevant MeSH terms:
Lovastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014