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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

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ClinicalTrials.gov Identifier: NCT01346670
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : May 3, 2011
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital

April 27, 2011
May 3, 2011
May 3, 2011
October 2006
October 2006   (Final data collection date for primary outcome measure)
Evaluation of the relative bioavailability by plasma concentration of LipoCol and lovastatin [ Time Frame: 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.
Same as current
No Changes Posted
The incidence rate of adverse event [ Time Frame: 1 week ]
The incidence rate of adverse event
Same as current
Not Provided
Not Provided
 
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
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteer
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.
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
Intervention: Drug: LipoCol and Mevacor
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Same as current
October 2006
October 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01346670
F950802
No
Not Provided
Not Provided
Hsingjin Eugene Liu, MD PhD, Department of Hematology-oncology, WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Liu Hsin-Gjin Eugene, M.D. Ph.D. Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP