Healthy Volunteer Clinical Trial
Official title:
Pharmacokinetic and Drug Interaction Study of Red Yeast Rice Capsules
Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a
significant cholesterol lowering effect which might be caused by addictive and/or
synergistic effects of lovastatin (monacolin K) with other monacolins and substances in
capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is
one capsule twice/day.
However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still
unknown.
The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice
capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.
This study will divide into two groups, single and multiple doses groups. In single dose
group, the subjects will receive one, two and four red yeast rice capsules under fed state
in period one to three, respectively. In multiple doses group, the subjects will receive red
yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days
washout period before crossover of treatments.
In single dose treatment, the blood samples will be drawn prior to the dosing, and 0.5, 1,
1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.
In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior
to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2,
2.5, 3, 4, 6, 8 and 12 hours after the 9th dosing.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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