NCT01527669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

July 11, 2012

Status Verified

February 1, 2012

Enrollment Period

Same day

First QC Date

January 12, 2012

Last Update Submit

July 9, 2012

Conditions

Healthy Subjects

Keywords

Red yeast ricelovastatinPharmacokinetics

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 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after oral administration red yeast rice capsule (LipoCol Forte)or lovastatin. All pharmacokinetic parameters were determined with lovastatin and lovastatin acid concentrations by non-compartment methods.

    1 weeks

Secondary Outcomes (1)

  • The incidence rate of adverse event

    1 weeks

Study Arms (2)

LipoCol Forte capsules

EXPERIMENTAL

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Drug: LipoCol Forte capsules

Lovastatin Tablet

EXPERIMENTAL

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Drug: Lovastatin Tablet

Interventions

LipoCol Forte capsulesDRUG

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

LipoCol Forte capsules
Lovastatin TabletDRUG

The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.

Lovastatin Tablet

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 23352857DERIVED

MeSH Terms

Interventions

Lovastatin

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

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

January 12, 2012

First Posted

February 7, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 11, 2012

Record last verified: 2012-02

Locations

TW(1)