Clinical trial NCT01527669: The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
Official title: The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Keywords: Red yeast rice
lovastatin
Pharmacokinetics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-02-07
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet after single oral administration in healthy subjects.

Detailed description: This study is two-ways crossover design. The subjects will receive a dose of four 600 mg LipoCol Forte Capsules or 20 mg Mevacor Tablet in fasted state in the morning. There is a minimum of a 6-days washout period before crossover of treatments.

Each subject will be admitted before administration of the investigational product in each period. Study responsible personnel will give the subjects a single tablet or four capsules in fasted state in the morning. The blood samples will be drawn prior to the dosing, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.

Observations will be conducted up to 12 hours after the dosing. If no particular health abnormalities are observed in each period, the subjects will be discharged on 12 hours after the dosing.

Eligibility 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 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.

Primary outcomes:
measure: Evaluation of the pharmacokinetic parameters of lovastatin and lovastatin acid in healthy subjects
timeFrame: 1 weeks
Secondary outcomes:
measure: The incidence rate of adverse event
timeFrame: 1 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Chin Yang, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen CH, Yang JC, Uang YS, Lin CJ. Improved dissolution rate and oral bioavailability of lovastatin in red yeast rice products. Int J Pharm. 2013 Feb 28;444(1-2):18-24. doi: 10.1016/j.ijpharm.2013.01.028. Epub 2013 Jan 23.