Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects

Healthy Subjects Clinical Trial

Official title: Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT01385020
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Completion date: July 2011