Healthy Subjects Clinical Trial
Official title:
Effect of Gemfibrozil on the Safety and Pharmacokinetics of Red Yeast Rice in Healthy Subjects
Verified date | August 2011 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Evaluation of the plasma concentration of creatine kinase (CK) and co-enzyme Q10 in healthy subjects | 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) | 1 week | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06248801 -
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
|
Phase 1 | |
Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 |