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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LipoCol Forte capsules | Experimental | The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. |
|
| Lovastatin Tablet | Experimental | The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipoCol Forte capsules | Drug | The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects | 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. | 1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of adverse event | The incidence rate of adverse event | 1 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jyh-Chin Yang, M.D. Ph.D | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23352857 | Derived | 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. |
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| ID | Term |
|---|---|
| D008148 | Lovastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Lovastatin Tablet | Drug | The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects. |
|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |