Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      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.

      Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides
      and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed
      lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although
      the combination of a fibrate and a statin is highly effective,concerns about an increased
      incidence of myopathy and even rhabdomyolysis have limited the widespread use of such
      combinations. Such combination therapies are prone to drug-drug interactions, which can lead
      to altered pharmacokinetic profiles of either drug, an effect observed for many statins in
      combination with fibrates. However, the drug-drug interactions have not been reported between
      red yeast rice capsule and gemfibrozil.

      The objective of the study is to evaluate the effect of gemfibrozil on the plasma
      concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice
      capsule in healthy volunteers. In addition, the investigators also measure the plasma
      concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.
    

Detailed description: 
      A randomized,crossover study design with 2 periods was used. The washout time between the
      periods was 4 days. In first period, 600 mg red yeast rice capsule (LipoCol) was administered
      orally with 240 mL water at 8 AM. In second period, subjects took 600 mg gemfibrozil (two
      Lopid 300-mg capsule) at 7 AM and 7 PM for 2 days. On day 3, subjects took 600 mg gemfibrozil
      at 7 AM then 600 mg red yeast rice capsule was administered orally with 240 mL water at 8 AM.
      The volunteers had fasted overnight, a breakfast and dinner was severed 0.5 hour after the
      administration of gemfibrozil. In addition, a high fat breakfast was served 0.5 hour before
      and standard meal was served 4 and 10 hours after the administration of red yeast rice
      (LipoCol).

      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 administration of red yeast rice(LipoCol)for detecting the plasma
      concentration of lovastatin and lovastatin acid. In addition, the blood samples will be drawn
      prior to the dosing, and 1, 2, 4, 6 and 12 hours after the administration of red yeast rice
      (LipoCol) for detecting the plasma concentration of creatine kinase (CK) and co-enzyme Q10.
    

Intervention name(s): Gemfibrozil & red yeast rice (LipoCol)
Intervention type(s): Drug
Intervention description(s): The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects.
Intervention MeSH terms: Gemfibrozil; Red yeast rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Red yeast rice; Gemfibrozil; Drug-drug interaction; Pharmacokinetics