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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01385020
First received: June 28, 2011
Last updated: October 13, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Gemfibrozil & red yeast rice (LipoCol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluation of the plasma concentration of creatine kinase (CK) and co-enzyme Q10 in healthy subjects [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Plasma concentrations of creatine kinase (CK) and co-enzyme Q10 were detected at following time: (Pre-dose (T0), and 1, 2, 4, 6, and 12 hours after oral administration red yeast rice capsule (LipoCol) with or without gemfibrozil)


Estimated Enrollment: 12
Study Start Date: July 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemfibrozil & red yeast rice (LipoCol)
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)
The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
  2. Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
  3. 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.

Exclusion Criteria:

  1. Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
  2. Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
  3. Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
  4. 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).
  5. Creatine kinase (CK) value greater than 1.5-fold normal value.
  6. A known hypersensitivity to statins and fibrates or their analogs.
  7. Permanent confinement to an institution.
  8. Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01385020

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jyh-Chin Yang, M.D. Ph.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01385020     History of Changes
Other Study ID Numbers: 201105057MC
Study First Received: June 28, 2011
Last Updated: October 13, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Red yeast rice
Gemfibrozil
Drug-drug interaction
Pharmacokinetics

Additional relevant MeSH terms:
Gemfibrozil
Red yeast rice
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014