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The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
This study has been completed.
Sponsor:
National Taiwan University Hospital
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01527669
First received: January 12, 2012
Last updated: July 9, 2012
Last verified: February 2012
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Purpose
The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet after single oral administration in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy Subjects | Drug: LipoCol Forte capsules Drug: Lovastatin Tablet | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects. |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects [ Time Frame: 1 weeks ]Plasma concentrations of lovastatin and lovastatin acid were detected at following time: (Pre-dose (T0), and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol Forte)or lovastatin. 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 weeks ]The incidence rate of adverse event
| Enrollment: | 12 |
| Study Start Date: | February 2012 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LipoCol Forte capsules
The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
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Drug: LipoCol Forte capsules
The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
|
|
Experimental: Lovastatin Tablet
The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
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Drug: Lovastatin Tablet
The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
|
Detailed Description:
This study is two-ways crossover design. The subjects will receive a dose of four 600 mg LipoCol Forte Capsules or 20 mg Mevacor Tablet in fasted state in the morning. There is a minimum of a 6-days washout period before crossover of treatments.
Each subject will be admitted before administration of the investigational product in each period. Study responsible personnel will give the subjects a single tablet or four capsules in fasted state in the morning. The blood samples will be drawn prior to the dosing, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.
Observations will be conducted up to 12 hours after the dosing. If no particular health abnormalities are observed in each period, the subjects will be discharged on 12 hours after the dosing.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
- Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
- No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
Exclusion Criteria:
- Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
- Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
- Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
- Creatine kinase (CK) value greater than 1.5-fold normal value.
- A known hypersensitivity to statins or their analogs.
- Permanent confinement to an institution.
- Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01527669
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527669
Locations
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
| Principal Investigator: | Jyh-Chin Yang, M.D. Ph.D | National Taiwan University Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01527669 History of Changes |
| Other Study ID Numbers: |
201110011MB |
| Study First Received: | January 12, 2012 |
| Last Updated: | July 9, 2012 |
Keywords provided by National Taiwan University Hospital:
|
Red yeast rice lovastatin Pharmacokinetics |
Additional relevant MeSH terms:
|
Lovastatin L 647318 Dihydromevinolin Red yeast rice Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017