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

NCT01385020 | Completed Phase 4

• 1 other identifier: 201105057MC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

Red yeast rice; Gemfibrozil; Drug-drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol) with or without gemfibrozil All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods.

  1 week

Secondary Outcomes (1)

• Evaluation of the plasma concentration of creatine kinase (CK) and co-enzyme Q10 in healthy subjects

  1 week

Study Arms (1)

Gemfibrozil & red yeast rice (LipoCol)

EXPERIMENTAL

The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects

Drug: Gemfibrozil & red yeast rice (LipoCol)

Interventions

Gemfibrozil & red yeast rice (LipoCol) DRUG

The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects.

Gemfibrozil & red yeast rice (LipoCol)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
• Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
• No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.

You may not qualify if:

• Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
• Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
• Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
• Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
• Creatine kinase (CK) value greater than 1.5-fold normal value.
• A known hypersensitivity to statins and fibrates or their analogs.
• Permanent confinement to an institution.
• Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Gemfibrozil; red yeast rice

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Jyh-Chin Yang, M.D. Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 17, 2011

Record last verified: 2011-08

Locations

TW (1)