Healthy Subjects Clinical Trial
Official title:
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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